Canon Medical Systems Corporation December 18, 2020

℅ Mr. Paul Biggins

Senior Director Regulatory Affairs
Canon Medical Systems USA, INC.
2441 Michelle Drive
TUSTIN CA 92780

Re: K203551
Trade/Device Name: Alphenix, INFX-8000V/B, INFX-8000V/S V9.1
Regulation Number: 21 CFR 892.1650
Regulation Name: Image-Intensified Fluoroscopic X-Ray System
Regulatory Class: Class II
Product Code: OWB
Dated: December 1, 2020
Received: December 4, 2020

Dear Mr. Biggins:

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# 04017.04.21
Silver Spring, MD 20993
www.fda.gov
K203551 - Paul Biggins 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,

For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0120
Food and Drug Administration Expiration Date: 0613012020
Indications for Use See PRA Statement below.

510(k) Number (if known)

K203551

Device Name

Alphenix, INFX-8000V/B, INFX-8000V/S V9.I

Indications for Use (Describe)

This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration.
The system is indicate for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen
and lower extremities.

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

1:8] Prescription Use (Part 21 CFR 801 Subpart D) 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 burdeni estimate or any other aspect
of this information collection, including1 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 0MB number."

FORM FDA 3881 (7/17) Page 1 of 1 PSC Pubtishmg Srn•�es (301) 443-6740 EF
K203551

510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance
with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92

1. SUBMITTER’S NAME
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara‐Shi, Tochigi‐ken, Japan 324‐8550

2. OFFICIAL CORRESPONDENT
Fumiaki Teshima
Senior Manager, Quality Assurance Department

3. CONTACT PERSON, U.S. AGENT and ADDRESS

Paul Biggins
Senior Director Regulatory Affairs
2441 Michelle Drive
Tustin, CA 92780
Phone (714) 730‐5000
Fax (714) 730‐1310
Email: [email protected]

4. MANUFACTURING SITE
Canon Medical Systems Corporation
1385 Shimoishigami
Otawara‐shi, Tochigi 324‐8550, Japan

5. ESTABLISHMENT REGISTRATION
9614698

6. DATE PREPARED
December 1, 2020

7. TRADE NAME(S)
Alphenix, INFX‐8000V/B, INFX‐8000V/S V9.1

8. DEVICE NAME
Interventional Fluoroscopic X‐ray System
9. CLASSIFICATION PANEL
Radiology
10. DEVICE CLASSIFICATION
Class II (per 21 CFR 892.1650)

11. PRODUCT CODE / DESCRIPTION

Product Code: OWB ‐ Image‐Intensified Fluoroscopic X‐ray System

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12. PERFORMANCE STANDARD
This device conforms to applicable Performance Standards for Ionizing Radiation Emitting
Products [21 CFR Subchapter J, Federal Diagnostic X‐ray Equipment Standard].

13. PREDICATE DEVICE

Classification Name Image‐Intensified Fluoroscopic X‐ray System
Product OWB
Regulation 21 CFR 892.1650
Regulatory Class II
Trade Alphenix, INFX‐8000V/B, V8.0
510(K) Number K181670 Clearance Date July 25, 2018

14. REASON FOR SUBMISSION

Modification of a cleared device

15. SUBMISSION TYPE

Special 510(k)

16. DEVICE DESCRIPTION

The Alphenix, INFX‐8000V/B, /S V9.1, is an X‐ray system that is capable of radiographic and fluoroscopic
studies and is used in an interventional setting. The system consists of a C‐arm/Ω‐arm which is equipped
with an X‐ray tube, beam limiter and X‐ray receptor, X‐ray controller, computers with system and
processing software, and a patient radiographic table.
17. INDICATIONS FOR USE
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional
angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for
blood vessels in the heart, brain, abdomen and lower extremities.
18. SUMMARY OF CHANGE(S)

This submission is to report the following items have been changed:

Summary of Software Changes
• V9.1 Software: System software changed from V8.0 to V9.1 for improved usability
and to support the new tube.
• Summary of other software changes since K181670
V8.0 to V8.3
o Pulsed fluoroscopy improvement
o Usability/Operability improvement
o Service Improvements (non‐clinical)
V8.3 to V9.0
o Operating System update from Windows 7 to Windows 10
o AlphaCT IQ improvement
o 2D IQ Improvement
o Dose optimization for DSA and spot fluoroscopy
o Usability/Operability improvement
o Service Improvements (non‐clinical)
o Cybersecurity improvement

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 Summary of Hardware Changes

X‐ray Tube DSRX‐T7634GFS (subject modification)

This x‐ray tube replaces the previous DSRX‐T7444GDS x‐ray tube. The changes to this tube
are as follows;
o A change in the instantaneous output at 10% power to 28.8 kW from the previous
22kW.
o A change in the pulsed fluoroscopy maximum mA from 200mA to 320mA
o ABC control is optimized for the new tube
o C‐arm CAS‐880A this was a modification to change the floor sensor back to an
earlier version that originally cleared via K081582.
X‐ray generator modification
o Increase in pulsed fluoroscopy peak power (kW) for cardiac x‐ray tube DRSX‐
T7444GDS from 17kW to 22kW at duty factor of 10% or less.
o X‐ray generator modification to reduce the heat generation in the power circuit.
o Change of the supplemental symbol for the DSRX‐T7444GDS from RUB to RXB
when used in conjunction with this x‐ray generator modification.
Usability/operability improvements (Internal Documentation LTF‐181670‐001)
o Modified foot switch for INFX‐8000V/B (bi‐plane configuration)
o Enabled one shot radiography at every acquisition program (DA, DSA, etc.) using
modified footswitch.
o Modified table side consoles are available.

19. SAFETY

The device is designed and manufactured under the Quality System Regulations as outlined in
21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable
parts of the IEC60601‐1 standards, its collateral standards and particular standards; IEC
60601‐2‐43 and IEC60601‐2‐28. All requirements of the Federal Diagnostic Equipment
Standard, as outlined in 21 CFR §1020, that apply to this device, will be met and reported via
product report.

LIST OF APPLICABLE STANDARDS

• ANSI AAMI ES 60601‐1:2005/(R) 2012+A1:2012
• IEC 60601‐1‐2:2014
• IEC 60601‐1‐3:2008 +A1:2013
• IEC 60601‐1‐6:2010 +A1:2013
• IEC 60601‐2‐28:2017
• IEC 60601‐2‐43:2010 +A1:2017
• IEC 62304:2006 +A1:2015
• IEC 62366:2007 +A1:2014

20. TESTING

Risk analysis and verification/validation testing conducted through bench testing demonstrate
that the established specifications for the device have been met. Testing included conformity

Page 3 of 4
 testing to IEC standards and phantom testing was conducted to verify image metrics related
to improvements and changes to the predicate device. Clinical images were deemed not
necessary for the aforementioned improvements via design control and risk management
activities.

This submission contains test data that demonstrates that the system modifications result in
performance that is equal to or better than the predicate system. Testing of the modified
system was conducted in accordance with the applicable standards published by the
International Electromechanical Commission (IEC) for Medical Devices and XR Systems.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document,
“Guidance for the Content of Premarket Submissions for Software Contained in Medical
Devices Document” issued on May 11, 2005, is also included as part of this submission.

Additionally, the design controls used for this device included risk management and all known
risks were mitigated to an acceptable level.

21. SUBSTANTIAL EQUIVALENCE

The Alphenix, INFX‐8000V/B, INFX‐8000V/S V9.1, is substantially equivalent to the INFX‐

8000V, V8.0, (K181670), marketed by Canon Medical Systems USA. The Alphenix, INFX‐
8000V/B, INFX‐8000V/S V9.1, includes system software change from V8.0 to V9.1, a new
cardiac x‐ray tube, usability improvements and operability improvements. The basic system
configuration, method of operation, base software and manufacturing process remain
unchanged from the cleared device. There are no new indications for use or intended use of
the device.

22. CONCLUSION

The Alphenix, INFX‐8000V/B, INFX‐8000V/S V9.1, performs in a manner similar to and is

intended for the same use as the predicate device, as indicated in product the labeling. The
modifications incorporated do not change the indications for use or the intended use of the
device. Based upon this information, conformance to standards, successful completion of
software validation, application of risk management and design controls and the performance
data presented in this submission it is concluded that the subject device is substantially
equivalent in safety and effectiveness to the predicate device. It is the contention of Canon
Medical Systems Corporation that all new safety issues have been addressed in the design of
this change and that adequate evidence of this is presented with this submission.

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