May 3, 2022

Allengers Medical Systems Limited

℅ Sanjeev Marjara
Director Technical
FDA Hall Unit-2, Bhankarpur,
Mubarakpur Road, Derabassi,
Distt. Mohali, Punjab 140507
INDIA

Re: K220311
Trade/Device Name: Cardiovascular Angiography System
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB, JAA, OXO
Dated: January 27, 2022
Received: February 2, 2022

Dear Sanjeev Marjara:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.32
Silver Spring, MD 20993
www.fda.gov
K220311 - Sanjeev Marjara Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,
Digitally signed by
Laurel M. Burk -S
Date: 2022.05.03
13:44:32 -04'00'
Laurel Burk
Assistant Director
Diagnostic X-ray Systems Team
DHT 8B: Division of Radiological Imaging Devices and
Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K220311

Device Name
Cardiovascular Angiography System

Indications for Use (Describe)

The Cardiovascular Angiography System is digital system with high frequency X-Ray generator for application in
cardiovascular procedures. This system used in catheterization labs uses high power x-ray pulses and digital imaging
system to visualize the vascular structures of human body.

Clinical applications may include (but not limited to) interventional cardiovascular procedures, Neurovascular
procedures, pacemaker implantable and high end investigations.

This system should be handled by persons who have been briefed in its professional handling and who have familiarized
themselves with the product by means of instructions for use. Intended use also means following the user manual and
observing the conditions for inspection and maintenance.

Exclusion: This system is not recommended for Mammography.

Contraindication: Exposure of X-Ray should be avoided during pregnancy.

Type of Use (Select one or both, as applicable)

 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740

EF
 510(k) Number: K220311
Allengers Medical Systems Limited
510(k) SUMMARY
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part
807.92.
1. Contact Person and Address
Company Name: Allengers Medical Systems Limited
Company Address: FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi, Distt
Mohali-140507, India
Telephone No: +91 1762-282600
+919872980168
[email protected]
Contact Person: Sanjeev K. Marjara
Date Prepared: 27.01.2022

2. Proposed Device:
Device (trade) name: Cardiovascular Angiography System
Model Name: Proxima FDX, Altima FDX Adv
Digiscan FDX-V8043, Digiscan FDX-V8030, Digiscan FDX-V8020
Digiscan FDX-V6543, Digiscan FDX-V6530, Digiscan FDX-V6520
Digiscan FDX-V4043, Digiscan FDX-V4030, Digiscan FDX-V4020
Digiscan FDX-V2743, Digiscan FDX-V2730, Digiscan FDX-V2720
Classification Name : Image-Intensified Fluoroscopic X-Ray System
Classification Panel: Radiology
Regulation Number : 21 CFR 892.1650
Device Class: Class II
Product Code: Primary Code : OWB
Subsequent Code : JAA and OXO for 1Digiscan FDX-VXXYY
3. Predicate Device:
Device (trade) name: Allura Xper FD Series and Allura Xper OR Table series
510(K) Number : K162859
Clearance Date : December 2, 2016
Classification Name: Image-Intensified Fluoroscopic X-Ray System,
Classification Panel: Radiology
Regulation Number : 21 CFR 892.1650
Device Class : Class II
Product Code: Primary Code : OWB
Subsequent Code : JAA

1
Where XX may be 80/65/40/27 and YY may be 43/30/20

Allengers Medical Systems Limited - 510(K) 5-0-1 Section 5-0

Allengers Medical Systems Limited
4. Reference devices:
Device (trade) name: Ziehim Vision RFD
510(K) Number : K203428
Clearance Date : March 17, 2021
Classification Name: Image-Intensified Fluoroscopic X-Ray System
Classification Panel: Radiology
Regulation Number : 21 CFR 892.1650
Device Class : Class II
Product Code: Primary Code : OWB
Subsequent Code : JAA, OXO
Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have
been previously cleared by FDA or tested and evaluated per guidance for submissi on
of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state
detectors used with device.
Table 1 List of Solid State X-Ray Image Detectors
Solid State Detectors 510(K) Numbers
Varex Imaging corporation ± Paxscan 2020 DXV K200218
Varex Imaging corporation ± Paxscan 3030 DXV K200218
Varex Imaging corporation ± Paxscan 4343DXV --
MX Imaging ± CFP 2222 K171755
MX Imaging ± CFP 3131 K171755
Thales Group ± Pixium Surgical 2121S-A K183040
Thales Group ± Pixium 2121S-AU K200218
Thales Group ± Pixium Surgical 3030S-A K172822
Thales Group ± Pixium 3030S-AU K200218
IRAY Technology ± Mercu 0909F K200218
Allengers Medical Systems Ltd - FP 2121 RF --
Allengers Medical Systems Ltd - FP 2121 HR --
Allengers Medical Systems Ltd - FP 3030 HR --

5. Device description:
The Cardiovascular Angiography system is designed to perform fluoroscopic & digital
radiographic studies and are used in interventional examinations. This system covers
the complete range of angiographic applications, cardiac angiography, neuro-
angiography, general angiography, surgery and surgical angiography, multipurpose
angiography, rotational angiography and digital radiographic/ fluoroscopic procedures.
The following components are configured to create the Cardiovascular Angiography
system:
1. Floor mounted C-arm (Altima FDX Adv) or Ceiling Mounted C-Arm (Proxima
FDX) or Mobile C-Arm (2Digiscan FDX-VXXYY), X-ray tube assembly and Solid
State X-Ray image detector
2. Patient Table
3. Ceiling suspended display(s)

2
Where XX may be 80/65/40/27 and YY may be 43/30/20

Allengers Medical Systems Limited - 510(K) 5-0-2 Section 5-0

Allengers Medical Systems Limited
4. Footswitch for releasing radiation
5. Control console for controlling the stand, patient table, collimator and imaging
system.
The following in Table 2 are the specific components for various configurations of the
system. A complete system will consist of a selection of one of the devices in each
category.
Table 2 Combination Details
Component Manufacture Model

Proxima FDX
X-Ray Generator Allengers XGEN-100CV
Altima FDX Adv
Proxima FDX
Altima FDX Adv
X-Ray Generator Allengers Digiscan FDX-V8043 XGEN-80CV
Digiscan FDX-V8030
Digiscan FDX-V8020
Digiscan FDX-V6543
X-Ray Generator Allengers Digiscan FDX-V6530 XGEN-65CV
Digiscan FDX-V6520
Digiscan FDX-V4043
X-Ray Generator Allengers Digiscan FDX-V4030 XGEN-40CV
Digiscan FDX-V4020
Digiscan FDX-V2743
X-Ray Generator Allengers Digiscan FDX-V2730 XGEN-27CV
Digiscan FDX-V2720

Siemens Proxima FDX Megalix CAT

125/35/80 125 GW
X-Ray Tube Healthcare
Altima FDX Adv Megalix CAT
GmbH 125/15/40/80122 GW
Canon Proxima FDX E79039X
X-Ray Tube Electron Tubes E79030X
and devices Altima FDX Adv E79016X
Proxima FDX
Altima FDX Adv
Digiscan FDX-V8043
Digiscan FDX-V8030
Digiscan FDX-V8020 G1082, G-1582BI,
X-Ray Tube Varex Imaging Digiscan FDX-V6543 G2090, G1092
Digiscan FDX-V6530
Digiscan FDX-V6520
Digiscan FDX-V4043
Digiscan FDX-V4030
Digiscan FDX-V4020

Allengers Medical Systems Limited - 510(K) 5-0-3 Section 5-0

Allengers Medical Systems Limited

Digiscan FDX-V2743
A-145, RAD-99,
X-Ray Tube Varex Imaging Digiscan FDX-V2730
RAD-99B, RAD-15
Digiscan FDX-V2720

Proxima FDX
Altima FDX Adv
Solid State X-
Digiscan FDX-V8020
Ray Image Varex Imaging Paxscan 2020 DXV
Digiscan FDX-V6520
Detectors
Digiscan FDX-V4020
Digiscan FDX-V2720
Proxima FDX
Altima FDX Adv
Solid State X-
Digiscan FDX-V8030
Ray Image Varex Imaging Paxscan 3030 DXV
Digiscan FDX-V6530
Detectors
Digiscan FDX-V4030
Digiscan FDX-V2730
Proxima FDX
Altima FDX Adv
Solid State X-
Digiscan FDX-V8043
Ray Image Varex Imaging Paxscan 4343DXV
Digiscan FDX-V6543
Detectors
Digiscan FDX-V4043
Digiscan FDX-V2743
Proxima FDX
Altima FDX Adv
Solid State X-
IRAY Digiscan FDX-V8020
Ray Image Mercu 0909F
Technology Digiscan FDX-V6520
Detectors
Digiscan FDX-V4020
Digiscan FDX-V2720
Proxima FDX
Altima FDX Adv Pixium 2121S-AU
Solid State X-
Digiscan FDX-V8020 Pixium Surgical
Ray Image Thales Group
Digiscan FDX-V6520 2121S-A
Detectors
Digiscan FDX-V4020
Digiscan FDX-V2720
Proxima FDX
Altima FDX Adv
Solid State X- Pixium 3030S-AU
Digiscan FDX-V8030
Ray Image Thales Group Pixium Surgical
Digiscan FDX-V6530
Detectors 3030S-A
Digiscan FDX-V4030
Digiscan FDX-V2730
Solid State X- Proxima FDX
CFP 2222
Ray Image MX Imaging Altima FDX Adv
Detectors Digiscan FDX-V8020

Allengers Medical Systems Limited - 510(K) 5-0-4 Section 5-0

Allengers Medical Systems Limited
Digiscan FDX-V6520
Digiscan FDX-V4020
Digiscan FDX-V2720
Digiscan FDX-V8030
Solid State X-
Digiscan FDX-V6530 CFP 3131
Ray Image MX Imaging
Digiscan FDX-V4030
Detectors
Digiscan FDX-V2730
Proxima FDX
Altima FDX Adv
Solid State X-
Digiscan FDX-V8020 FP 2121 RF
Ray Image Allengers
Digiscan FDX-V6520 FP 2121 HR
Detectors
Digiscan FDX-V4020
Digiscan FDX-V2720
Proxima FDX
Altima FDX Adv
Solid State X-
Digiscan FDX-V8030
Ray Image Allengers FP 3030 HR
Digiscan FDX-V6530
Detectors
Digiscan FDX-V4030
Digiscan FDX-V2730

Proxima FDX C Tab F FDX

Patient Table Allengers C Tab FXL FDX
Altima FDX Adv C Tab FCV FDX
Digiscan FDX-V8043
Digiscan FDX-V8030
Digiscan FDX-V8020
Digiscan FDX-V6543
Digiscan FDX-V6530
Digiscan FDX-V6520 C Tab M FDX
Patient Table Allengers
Digiscan FDX-V4043 Vascu Tab FDX
Digiscan FDX-V4030
Digiscan FDX-V4020
Digiscan FDX-V2743
Digiscan FDX-V2730
Digiscan FDX-V2720

Allengers Medical Systems Limited - 510(K) 5-0-5 Section 5-0

Allengers Medical Systems Limited
6. Indications for Use:
The Cardiovascular Angiography System is digital system with high frequency X-Ray
generator for application in cardiovascular procedures. This system used in
catheterization labs uses high power x-ray pulses and digital imaging system to
visualize the vascular structures of human body.

Clinical applications may include (but not limited to) interventional cardiovascular
procedures, Neurovascular procedures, pacemaker implantable and high end
investigations.

This system should be handled by persons who have been briefed in its professional
handling and who have familiarized themselves with the product by means of
instructions for use. Intended use also means following the user manual and observing
the conditions for inspection and maintenance.

Exclusion: This system is not recommended for Mammography.

Contraindications: Exposure of X-Ray should be avoided during pregnancy.

7. Technological Characteristics Comparison to Predicate & Reference Devices:

The Cardiovascular Angiography Systems having set of components similar to the
Allura Xper FD Series and Allura Xper OR Table series (K162859) and Ziehm Vision
RFD (K203428) as compared in Table 3 found below in this Section. This table below
shows that the systems are either similar, or the same, as the predicate & reference
device.

8. Software Feature
Synergy FP FDX & Synergy FDX-CR imaging software is a Digital Imaging System
(DIS) provides useful functions to manage X-Ray images obtained from
Cardiovascular Angiography System.
The software feature set and functions is essentially the same as the device, with the
system complying with DICOM 3.0 specifications .Refer to section 9 Image processing
and storage of the table 3 for a list of top level functions

9. Substantial Equivalence:
The Cardiovascular Angiography system are substantially equivalent to the
commercially available Allura Xper FD series and Allura Xper OR Table series
(K162859) & Ziehm Vision RFD (K203428). Functional and specification differences
are identifying in the following table.

Allengers Medical Systems Limited - 510(K) 5-0-6 Section 5-0

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Table 3: Functional and specification differences
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
1. 510(k) This submission K162859 K203428
2. Product Code
Product OWB, JAA &
3
Classification OXO for Digiscan FDX- OWB and JAA OWB , JAA & OXO Same
Code V XXYY
3. Product Classi fication
Classification 21 CFR 892.1650 21 CFR 892.1650 21 CFR 892.1650 Same
4. Indication for Use
The Allura Xper series and The Ziehm Vision RFD
The Cardiovascular the Allura Xper OR Table is intended for use in
Angiography system is series (within the limits of providing medical
digital system with high the used OR table) are imaging for adult and
frequency X-Ray generator intended for use pediatric populations,
for application in on human patients to using pulsed and
cardiovascular procedures. perform: continuous fluoroscopic
This system used in ‡ 9DVFXODU FDUGLRYDVFXODU digital imaging, as well
catheterization labs uses and neurovascular imaging as digital subtraction
high power x-ray pulses and applications, including and cine image capture
digital imaging system to diagnostic, interventional during diagnostic
visualize the vascular and minimally interventional and
structures of human body. invasive procedures. This surgical procedures
includes, e.g., peripheral, where int ra-operative
Clinical applications may cerebral, thoracic and imaging and Essentially
include (but not limited to) abdominal angiography, as visualization of the same
interventional cardiovascular well as P TAs, stent complex anatomical
procedures, Neurovascular placements, embolisations structures of both lower Note: There
procedures, pacemaker and thrombolysis. and higher contrast are no
implantable and high end ‡ &DUGLDF LPDJLQJ density are required. differenc es
investigations. applications including Such procedures may between
Indications for
This system should be diagnostics, interventional include but are not the subject
Use
handled by persons who and minimally invasive limited to those of devic e and
have been briefed in its procedures (such as interventional the predicate
professional handling and PTCA, stent placing, cardiology, heart with respect
who have familiarized atherectomies), surgery, hybrid to indication
themselves with the product pacemak er implantations, procedures, and intended
by means of instructions for and electrophysiology interventional use.
use. Intended use also (3  ‡ 1RQ-vascular radiology,
means following the user interventions such as interventional
manual and observing the drainages, biopsies and angiography,
conditions for ins pection and vertebroplasties electrophysiology,
maintenance. procedures. pediatrics, endoscopic,
Additionally: urological,
Exclusion: This system is ‡ 7KH $OOXUD ;SHU DQG gastroenterology,
not recommended for Allura Xper OR Table orthopedic,
Mammography. series is compatible wit h a maxillofacial surgery,
hybrid Operating Room. neurology,
Contraindications: ‡ $OOXUD ;SHU )' LV neurosurgery, critical
Exposure of X-Ray should compatible with specified care, emergency room
be avoided during magnetic navigation procedures, and those
pregnancy. systems. procedures visualizing
‡ &RPELQHG ZLWK D structures of the

3
Where XX may be 80/65/40/27 and YY may be 43/30/20

Allengers Medical Systems Limited - 510(K) 5-0-7 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
qualified, compatible OR cervical, thoracic, and
table, the Allura Xper OR lumber regions of the
Table series can be used spine, and joint
for imaging in the Hybrid fractures of the upper
OR within the applications and lower extremities,
domains Neuro, Vascular, and where digital
Non Vascular and Cardiac. image data is required
The OR table can also be for computer aided
used standalone for surgery proc edures
surgical use in the OR. and whenever the
clinician benefits from
the high degree of
geometric imaging
accuracy, and where
such fluoroscopic, cine
and DSA imaging is
required. The
visualization of such
anatomic al structures
assists the clinician in
the clinical outcome.
This device does not
support direct
radiographic film
exposures and is not
intended for use in
performing
mammography. The
system is not intended
for use near MRI
systems.
5. X-Ray Generator
Microprocessor-controlled, Microprocessor-controlled, Monoblock and High Same as
Type high frequency converter high frequency converter Frequency Generator Predicate
generator generator devic e
XGE N-100CV 100KW
XGE N-80CV 80KW
30 KW Similar
Power Rating XGE N-65CV 65KW 100 KW
25 KW (SE #1)
XGE N-40CV 40KW
XGE N-27CV 27KW
100 kW(1000mA at 100kV)
Nominal power 30 kW(300mA at 100
80 KW(800 mA at 100 KV)
(highest 100 kW (1000 mA at 100 kV) Similar
65 KW(650 mA at 100 KV)
electrical kV) 25 KW(250mA at 100 (SE #2 )
40 KW(400 mA at 100 KV)
power) kV)
27 KW(270 mA at 100 KV)
Digital Radiographic Mode
Same as
Radiographic
1-1000 mA 1-1000 mA 1-300 mA predicate
mA (Max.)
devic e
Same as
Radiographic
40-125 40-125 40-120 Predicate
KV
Device

Allengers Medical Systems Limited - 510(K) 5-0-8 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
Fluoroscopic Mode
Same as
Fluoroscopic
Pulsed 200 mA max Pulsed 200 mA max Pulsed 300 mA max Predicate
mA
Device
Same as
Fluoroscopic
40-125 40-125 40-120 Predicate
KV
Device
Same as
Pulsed
Upto 30 fps upto 30 fps upto 25 fps Predicate
fluoroscopy
Device
ABS Control Yes Yes Yes Same
6. X-Ray Tube
Megalix CA T 125/35/80 125 --
Model MRC-GS 0508 --
GW
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
3 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Dual Focus 0.4/0.8 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 8.5º 9º --
(SE #3)
Optional
Megalix CA T125/15/40/80 --
Model MRC-GS 0508 --
122 GW
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
3 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Triple Focus 0.3/0.6/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 12.5º 9º --
(SE #3)
Optional
Model E79039X MRC-GS 0508 -- --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
2.1 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Dual Focus 0.6/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 11º 9º --
(SE #3)
Optional
Model E79030X MRC-GS 0508 -- --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
3 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Dual Focus 0.6/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6 Similar

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Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
Size, mm (SE #3)
Similar
Anode Angle 11º 9º --
(SE #3)
Optional
Model E79016X MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
3 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Triple Focus 0.3/ 0.6/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 11º 9º --
(SE #3)
Optional
Model G2090TRI MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
2 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Triple Focus 0.3/ 0.6/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 12º 9º --
(SE #3)
Optional
Model G1582B I MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
1.5 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Triple Focus 0.3/ 0.6/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 10º 9º --
(SE #3)
Optional
Model G1082 MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
1 MHU 2.4 MHU 365 KHU
heat storage (SE #3)
Focal Spot Similar
Dual Focus 0.3/1.0 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 10º 9º --
(SE #3)
Optional
Model G1092 MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
1 MHU 2.4 MHU 365 KHU
heat storage (SE #3)

Allengers Medical Systems Limited - 510(K) 5-0-10 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
Focal Spot Similar
Dual Focus 0.6/1.2 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6
Size, mm (SE #3)
Similar
Anode Angle 12º 9º --
(SE #3)
Optional
Model RAD-15 MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Same as
Max. anode
365 KHU 2.4 MHU 365 KHU Referenc e
heat storage
Device
Same as
Focal Spot
Dual Focus 0.3/0.6 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6 Referenc e
Size, mm
Device
Similar
Anode Angle 10º 9º --
(SE #3)
Optional
Model RAD-99 / RA D-99B MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
300 KHU 2.4 MHU 365 KHU
heat storage (SE #3)
Same as
Focal Spot
Dual Focus 0.3/0.6 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6 Referenc e
Size, mm
Device
Similar
Anode Angle 10º 9º --
(SE #3)
Optional
Model A-145 MRC-GS 0508 --
Tube Type Rotating Anode Rotating Anode Rotating Anode Same
Max. anode Similar
300 KHU 2.4 MHU 365 KHU
heat storage (SE #3)
Same as
Focal Spot
Dual Focus 0.3/0.6 Dual Focus 0.5/0.8 Dual Focus 0.3/0.6 Referenc e
Size, mm
Device
Similar
Anode Angle 10º 9º --
(SE #3)
7. Solid State X-Ray Image Detectors
Thales, Pixium Surgical ---
Make -- --
2121S-A
Same as
Type Amorphous Silicon -- Amorphous Silicon Referenc e
devic e
Same as
Active Area 21 cm x 21 cm 21 cm x21 cm 19.9 cm x 19.9 cm predicate
devic e
Same as
Pixel Matrix 1,344 x 1,344 1,344 x 1,344 1,024 x 1,024
predicate

Allengers Medical Systems Limited - 510(K) 5-0-11 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
devic e
Same as
DQE 77 % at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm predicate
devic e
Modulation
Same as
Trans fer
59% 59% 55% predicate
Function (MTF)
devic e
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Same as
Pixel Pitch 154 μm 154μm 194μm predicate
devic e
Optional
Make 9DUH[¶V  3D[VFDQ ';9 -- -- --
Same as
Type Amorphous Silicon --- Amorphous Silicon Referenc e
devic e
Similar
Active Area 42.7cm x 42.7cm 38 cm x 30 cm 29.8 cm x 29.8 cm
(SE #4)
Similar
Pixel Matrix 3,072 x 3,072 2,480 x 1,920 1,536 x 1,536
(SE #4)
Similar
DQE 78% at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Trans fer Similar
54% 60% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 139μm 154μm 194μm
(SE #4)
Optional
Make 9DUH[¶V  3D[VFDQ  ';9 -- -- --
Same as
Type Amorphous Silicon -- Amorphous Silicon Referenc e
devic e
Same as
Active Area 29.8 cm x 29.8 cm 29 cm x26 cm 29.8 cm x 29.8 cm Referenc e
devic e
Same as
Pixel Matrix 1,536 x 1,536 1,560 x 1,440 1,536 x 1,536 Referenc e
devic e
Same as
DQE 80% at 0lp/mm 70% at 0lp/mm 80% at 0lp/mm Referenc e
devic e
Modulation Same as
55% 59% 55%
Trans fer Referenc e

Allengers Medical Systems Limited - 510(K) 5-0-12 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
Function (MTF) devic e
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Same as
Pixel Pitch 194μm 184μm 194μm Referenc e
devic e
Optional
Make 9DUH[¶V  3D[VFDQ  ';9 -- -- --
Same as
Type Amorphous Silicon -- Amorphous Silicon Referenc e
devic e
Same as
Active Area 19.9 cm x 19.9 cm 21 cm x 21 cm 19.9 cm x 19.9 cm Referenc e
devic e
Same as
Pixel Matrix 1,024 x 1,024 1,344 x 1,344 1,024 x 1,024 Referenc e
devic e
Same as
DQE 80% at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm Referenc e
devic e
Modulation
Same as
Trans fer
55% 59% 55% Referenc e
Function (MTF)
devic e
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Same as
Pixel Pitch 194μm 154μm 194μm Referenc e
devic e
Optional
Make ,5$< µV 0HUFX ) -- -- --
Type Amorphous Silicon -- Amorphous Silicon --
Similar
Active Area 22.9 cm x 22.9 cm 21 cm x 21 cm 19.9 cm x 19.9 cm
(SE #4)
Same as
Pixel Matrix 1,024 x 1,024 1,344 x 1,344 1,024 x 1,024 Referenc e
Device
Same as
DQE 77% at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm Predicate
devic e
Modulation
Trans fer Similar
61% 59% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Pixel Pitch 205μm 154μm 194μm Similar

Allengers Medical Systems Limited - 510(K) 5-0-13 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
(SE #4)
Optional
Make Thales, Pixium 2121S-A U -- -- --
Same as
Type Amorphous Silicon -- Amorphous Silicon Referenc e
devic e
Similar
Active Area 20.5 cm x 20.5 cm 21 cm x 21 cm 19.9 cm x 19.9 cm
(SE #4)
Same as
Pixel Matrix 1,024 x 1,024 1,344 x 1,344 1,024 x 1,024 Referenc e
Device
Similar
DQE 78 % at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Trans fer Similar
53 % 59% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 200 μm 154μm 194μm
(SE #4)
Optional
Make MX CFP 2222 -- -- --
Similar
Type CMOS -- Amorphous Silicon
(SE #4)
Similar
Active Area 21.7 cm x 21.7 cm 21 cm x 21 cm 29.8 cm x 29.8 cm
(SE #4)
Similar
Pixel Matrix 2,170 x 2,170 1,344 x 1,344 1,536 x 1,536
(SE #4)
Similar
DQE 72% at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Trans fer Similar
60% 59% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 100 μm 154μm 194μm
(SE #4)
Optional
Make MX CFP 3131 -- -- --
Similar
Type CMOS -- Amorphous Silicon
(SE #4)
Similar
Active Area 30.9 cm x 30.7 cm 29 cm x 26 cm 29.8 cm x 29.8 cm
(SE #4)
Similar
Pixel Matrix 3,096 x 3,072 1,560 x 1,440 1,536 x 1,536
(SE #4)

Allengers Medical Systems Limited - 510(K) 5-0-14 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
Similar
DQE 72% at 0lp/mm 70% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Trans fer Similar
60% 59% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
14 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 99 μm 184μm 194μm
(SE #4)
Optional
Thales, Pixium Surgical --
Make -- --
3030S-A
Same as
Type Amorphous Silicon -- Amorphous Silicon Referenc e
Device
Similar
Active Area 30.1 cm x 30.1 cm 29 cm x 26 cm 29.8 cm x 29.8 cm
(SE #4)
Similar
Pixel Matrix 1,956 x 1,956 1,560 x 1,440 1,536 x 1,536
(SE #4)
Similar
DQE 75 % at 0lp/mm 70% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Same as
Trans fer
59% 59% 55% Predicate
Function (MTF)
Device
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 154 μm 184μm 194μm
(SE #4)
Optional
Make Thales, Pixium 3030S-A U -- -- --
Same as
Type Amorphous Silicon -- Amorphous Silicon Referenc e
Device
Similar
Active Area 30 cm x 30 cm 29 cm x 26 cm 19.9 cm x 19.9 cm
(SE #4)
Similar
Pixel Matrix 1,536 x 1,536 1,560 x 1,440 1,024 x 1,024
(SE #4)
Similar
DQE 78 % at 0lp/mm 70% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Same as
Trans fer
59% 59% 55% Predicate
Function (MTF)
devic e
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Pixel Pitch 200 μm 184μm 194μm Similar

Allengers Medical Systems Limited - 510(K) 5-0-15 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
(SE #4)
Optional
Make Allengers, FP 2121RF -- -- --
Amorphous Silicon TFT/P D
Type -- Amorphous Silicon --
matrix panel
Same as
Active Area 21 cm x 21 cm 21 cm x 21 cm 19.9 cm x 19.9 cm Predicate
Device
Same as
Pixel Matrix 1,024 x 1,024 1,344 x 1,344 1,024 x 1,024 Referenc e
Device
Same as
DQE 77% at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm Predicate
devic e
Modulation
Trans fer Similar
61% 59% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 205μm 154μm 194μm
(SE #4)
Optional
Make Allengers, FP 2121HR -- -- --
Amorphous Silicon TFT/P D
Type -- Amorphous Silicon --
matrix panel
Similar
Active Area 21.3 cm x 21.3 cm 21 cm x 21 cm 19.9 cm x 19.9 cm
(SE #4)
Similar
Pixel Matrix 1,536 x 1,536 1,344 x 1,344 1,024 x 1,024
(SE #4)
Similar
DQE 73% at 0lp/mm 77% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Trans fer Similar
61% 59% 55%
Function (MTF) (SE #4)
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 139 μm 154μm 194μm
(SE #4)
Optional
Make Allengers, FP 3030 HR -- -- --
Same as
Amorphous Silicon TFT/P D
Type -- Amorphous Silicon Referenc e
matrix panel
devic e
Similar
Active Area 30.7 cm x 30.7 cm 29 cm x26 cm 29.8 cm x 29.8 cm
(SE #4)

Allengers Medical Systems Limited - 510(K) 5-0-16 Section 5-0

Allengers Medical Systems Limited
Allura Xper FD Series
Cardiova scular Justi fication
and Allura Xper OR Table Ziehm Vision RFD
Feature Angiography System for
serie s (Reference Device)
(Subject Device) differences
(Predicate Device)
Similar
Pixel Matrix 2,048 x 2,048 1,560 x 1,440 1,536 x 1,536
(SE #4)
Similar
DQE 67% at 0lp/mm 70% at 0lp/mm 80% at 0lp/mm
(SE #4)
Modulation
Same as
Trans fer
55% 59% 55% Referenc e
Function (MTF)
devic e
at 1lp/mm
A/D
16 bit 16 bit 16 bit Same
Conversion
Similar
Pixel Pitch 150 μm 184μm 194μm
(SE #4)
8. Ceiling Suspension Viewing Monitors
Size, in (Min) N/A
Similar
(Examination ´ ´
(SE #5)
Room)
Size, in (Min) N/A
Similar
(Console ´ ´
(SE #5)
Room)
N/A Same as
Touch Screen Yes Yes Predicate
devic e
9. Image Processing and storage
x Pulsed
x Pulsed Fluoroscopy x Pulsed Fluoroscopy
Imaging Mode Fluoroscopy Same
x Digital Spot x Digital Spot
x Digital Spot
Internal HDD drive,
Video storage Internal HDD drive, USB, Internal HDD drive, USB,
USB, Same
type CD/ DV D-RW drive CD/ DV D-RW drive
CD/ DV D-RW drive
Image
Detector Dependant Detector Dependant Detector Dependant Same
Interference
LIH Yes Yes Yes Same
Dicom
Yes Yes Yes Same
conformance
PACS
Ethernet or WLAN Ethernet or WLAN Ethernet or WLAN Same
Interfaces
Hard copy Printer and DICOM
Printer and DICOM print Printer and DICOM print Same
devic es print
10. Power Requirement
400 VAC ,(±10% ) 50/60 Hz Essentially
(Except 40KW & 27KW machines )
the Same as
Power 400 VAC, (±10% ) 50/60 110/240 VAC, (±10% )
predicate &
Requirement 110/230 VAC, (±10% ) , Hz 50/60 Hz
reference
50/60 Hz
(For 40KW & 27KW machines ) devic e

Allengers Medical Systems Limited - 510(K) 5-0-17 Section 5-0

Allengers Medical Systems Limited
Difference Discussion
SE- # Substantial Equivalence discussion
#1 & #2
The subject device provides with different X-Ray Generators perform similar or
better compared to predicate and Reference device in terms of performance
specification. For XGEN-100CV, the performance specification is almost identical to
SE#1
predicate device in terms of kV and tube current. For XGEN-80CV, XGEN-65CV,
& #2
XGEN-40CV & XGEN-27CV, the generator capacity is sufficient to meet the
fluoroscopic and digital radiographic exposure requirements and have higher
maximum power output as compare to Reference device. Such differences in
performance do not raise additional risk concerns.
#3
There are many X-Ray tubes available due to equipment design considerations. The
tubes were tested and information is included in the Operator and Service Manuals.
SE#3 Any differences between the subject device and predicate & reference device do not
change or add new potential safety risks. Therefore, it is our determination that
WKHUH LV ³1R LPSDFW RQ VDIHW\ RU HIILFDF\´ DQG WKHUH DUH QR QHZ SRWHQWLDO RU
increased safety risks concerning this difference.
#4
The Subject device utilized different Solid State X-Ray Image Detectors (FPD) as
compare to predicate device Allura Xper FD Series and Allura Xper OR Table series
(K162859) & reference device Ziehm Vision RFD (K203428), however Detector
SE#4 technology is comparable to predicate device and reference device as per the SSXI
Guidance document .The FPD used along with subject device are already cleared
by FDA and does not raise the level of safety concern and affect any effectiveness.
The relevant 510(k) approval numbers are K171755, K183040 K172822 and
K200218.
#5
The Cardiovascular Angiography System utilized monitors with same resolution as
the predicate device Allura Xper FD Series and Allura Xper OR Table series
SE #5 (K162859) and Reference device Ziehm Vision RFD (K203428), however the screen
size is slightly ELJJHU 7KHUHIRUH LW LV RXU GHWHUPLQDWLRQ WKDW WKHUH LV ³1R LPSDFW RQ
VDIHW\ RU HIILFDF\´ DQG WKHUH DUH QR QHZ SRWHQWLDO RU LQFUHDVHG VDIHW\ ULVNV
concerning this difference.

10. Technological characteristics comparison to predicate & Reference device:

The indications for use, operating principle, technical specifications such as X-Ray
tube head and generator as well as safety characteristics of Cardiovascular
Angiography system models are identical to those of the predicate & reference device.
This System is designed as a set of components (X-Ray tube and housing, detector,
digital imaging system, collimator, generator etc.) similar to the predicate device Allura
Xper FD Series and Allura Xper OR Table series (K162859) and Reference device
Ziehm Vision RFD (K203428). Based on the recognized standard conformity
evidences related to electro-mechanical, software-, and risk management, Allengers
Medical Systems certifies that technological characteristics of Cardiovascular
Angiography system models are substantially equivalent to Allura Xper FD Series and
Allura Xper OR Table series (K162859), the predicate device and Ziehm Vision RFD
(K203428) the reference device.

Allengers Medical Systems Limited - 510(K) 5-0-18 Section 5-0

Allengers Medical Systems Limited
11. Performance Testing
Testing for verification and validation of the device was found acceptable to support
the claims of substantial equivalence. Performance testing included functional testing
of all motions systems with respect to design specifications. Additional engineering
bench testing was performed including: the non-clinical testing identified in the
guidance for submission of 510(k) for Solid state X-Ray imaging devices (SSXI);
Demonstration of system performance and an Imaging performance evaluation. Safety
compliance checking was evaluated according to IEC 60601-1: 2005/ A1:2012.
Allengers Medical Systems Ltd certifies conformance to Voluntary standards covering
electrical and Mechanical safety.

In conclusion, the identified risk of electrical hazards was mitigated and it is the
Allengers opinion that Cardiovascular Angiography system appears to be as safe and
effective as predicate & reference device.

12. Software Features and Testing:

6RIWZDUH 'RFXPHQWDWLRQ IRU D 0RGHUDWH /HYHO RI FRQFHUQ VRIWZDUH SHU )'$¶V
*XLGDQFH GRFXPHQW ³*XLGDQFH IRU WKH &RQWHQW RI 3UHPDUNHW 6XEPLVVLRQ IRU VRIWZDUH
FRQWDLQHG LQ 0HGLFDO 'HYLFH´ LV DOVR LQFOXGHG DV SDUW RI WKLV VXEPLVVLRQ

13. Description of Non Clinical & Clinical testing

Non Clinical performance testing has been performed on the Cardiovascular
Angiography system and it demonstrates compliance with the following 21 CFR
Federal Performance Standards:
x 1020.30 Diagnostic X-Ray Systems and their major components
x 1020.32 Fluoroscopic equipment
x 1040.10 Laser products
and with the following relevant voluntary FDA Recognized Consensus Standards as
listed in the table below:

Reference Standard
Recognition Product
Title of standard Number and Development
Number Area
date organization
Medical Electrical Equipment ±
Part 1: General requirements for 60601-1:2012,
19-4 General IEC
basic safety and essential ed. 3.1
performance
Medical electrical equipment ± Part
1-2: General requirements for basic
60601-1-2
safety and essential performanc e ±
19-8 General Edition 4.0 IEC
Collat eral Standard:
2014-02
Electromagnetic Compatibility ±
Requirements and tests
Medical Electrical Equipment Part
1-3: General Requirements for
60601-1-3
Basic Safety and Essential
12-269 Radiology Edition 2.1 IEC
Performance. -Collateral Standard:
2013-04
Radiation Protection in Diagnostic
X-Ray Equipment.
Particular requirements for the 60601-2-43
12-308 Radiology safety of X-Ray equipment for Edition 2.1, IEC
interventional procedures 2017

Allengers Medical Systems Limited - 510(K) 5-0-19 Section 5-0

Allengers Medical Systems Limited

Medical Electrical Equipment- Part

2-54: Particular Requirements for 60601-2-54,
12-296 Radiology the Basic Safety and Essential (Edition 1.1 IEC
Performance of X-Ray Equipment 2015).
for Radiography and Radioscopy
Medical device software ± S oft ware 62304 (E dition
13-79 General IEC
life cycle processes 1.1, 2015)
Medical Electrical Equipment Part
1- *HQHUDO 5HTXLUHPHQWV‡ IRU 60601-1-6,
5-89 General Basic Safety and Essential (Edition 3.1 IEC
Performance- Collateral Standard: 2013).
Usability
Application of Us ability Engineering 62366-1 Edition
5-114 General IEC
to Medical Devices 1.0 2015-02
Medical devices ± application of
General I 14971 Second
5-40 risk management to medical ISO
(QS/RM) Edition 2007-03
devic es
Safety of laser products ± Part 1: 60825-1 Edition
12-273 Radiology Equipment classification, and 2.0 IEC
requirements 2007-03
Table 4: FDA Guidance Documents
FDA Guidance Documents and Effective Date
Guidance for Industry and FDA Staff ± User Fees and Refunds for Premarket
1 Notification Submissions 510(k)
Document issued on October 2, 2017
Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy
2 for 510(k)s
Document issued on September 13, 2019.
Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s -
3 Guidance for Industry and FDA Staff
Document issued on September 13, 2019.
Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:
4 Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Document Issued on July 28, 2014
*XLGDQFH IRU ,QGXVWU\ DQG )'$ 6WDII *XLGDQFH IRU WKH 6XEPLVVLRQ 2I  N ¶V IRU Solid
5 State X-ray Imaging Devices
Document issued on September 1, 2016
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket
6 Submission for Software in Medical Devices
Document issued on May 11, 2005
Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in
7 Medical Devices
Document issued on September 27, 2019.
Guidance for Industry and FDA Staff: Applying Human Factors and Usability
8 Engineering to Medical Devices.
Document issued February 3, 2016
Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device
9 Premarket Notifications.
Document issued on November 28, 2017
Guidance for Industry and FDA Staff: Content of Premarket Submissions for
10 management of Cybersecurity in Medical devices.
Document issued on October 2, 2014.
Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic
11 Compatibility (EMC) of Electrically-Powered Medical Devices
Document issued on July 11, 2016
Allengers Medical Systems Limited - 510(K) 5-0-20 Section 5-0
Allengers Medical Systems Limited
Non-clinical verification test results demonstrate that the Cardiovascular Angiography
system complies with the aforementioned international and FDA recognized
consensus standards and FDA guidance documents. Also No clinical data is
necessary to evaluate safety or effectiveness for purposes of determining substantial
equivalence of the proposed device. Bench testing was performed to assess the
device safety and effectiveness.

14. Substantial Equivalence Conclusion:

Cardiovascular Angiography system does not introduce any new indications for use,
nor does the use of the systems result in any new potential hazards. The subject
device is substantially equivalent to the Allura Xper FD Series and Allura Xper OR
Table series (K162859). The intended use, the design principle, and the applicable
standards for the subject device are identical to those of the predicate & reference
device. Some characteristics, for example, their appearance, the user interfaces and
the physical dimensions are different. However, the performance test and non-clinical
consideration result demonstrate that these differences do not raise any new
questions of safety and effectiveness. Therefore, it is the Allengers opinion that the
subject device appears to be as safe and effective as the predicate & reference
device.

Allengers Medical Systems Limited - 510(K) 5-0-21 Section 5-0