HITACHI VERSIFLEX

K991231 · Hitachi Medical Systems America, Inc. · IZI · May 24, 1999 · Radiology

Device Facts

• Record ID: K991231
• Device Name: HITACHI VERSIFLEX
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: IZI · Radiology
• Decision Date: May 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

Device Story

Hitachi Versiflex is a multidirectional fluoroscopic, angiographic, and radiographic system. Device integrates a C-arm supporting base with a patient tilting table. System accepts X-ray radiation as input, converting patterns into images via electronic amplification and recording. Used in clinical settings for multi-purpose examinations, including cardiac and vascular imaging with contrast media. Operated by healthcare professionals to assist in diagnostic and interventional procedures. Output is a visual image used by clinicians to assess anatomical structures and guide clinical decision-making.

Clinical Evidence

Bench testing only; device tested to UL-2601 standards.

Technological Characteristics

Multidirectional C-arm fluoroscopic/angiographic and radiographic system; integrated patient tilting table; X-ray generating unit; image processing system; electronic amplification and recording; tested to UL-2601.

Indications for Use

Indicated for visualization of anatomical structures via X-ray imaging and electronic amplification; includes visualization of heart and blood vessels when used with contrast medium. Intended for prescription use.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Hitachi SX-VA30 Fluoroscopy/Angiography System (K964990)

Submission Summary (Full Text)

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K991231

## 510(k) Summary

# Hitachi Versiflex

Common/Classification Name: System, 21 CFR 892.1650, 892.1650

Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087-2371

330-425-1313, 330-425-1410 (FAX) Contact: John T. Newland, Prepared: March 19, 1999

### LEGALLY MARKETED PREDICATE DEVICES A.

The Hitachi VERSIFLEX is substantially equivalent to the presently marketed Hitachi SX-VA30 Fluoroscopy/Angiography System (as cleared in K964990). The VERSIFLEX is manufactured by Hitachi Medical Corporation, Hitachi Hagoromo Building, 1-2-10 Uchi-Kanda, Chiyoda-Ku, Tokyo, 101, Japan. This 510(k) is submitted because the VERSIFLEX is a new device.

### DEVICE DESCRIPTION B.

The Hitachi VERSIFLEX is a new product. The VERSIFLEX is a multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system. With this system it is possible to carry out fluoroscopic/angiographic or radiographic examinations from various angles, and in combination with an X-ray generating unit and an image processing system, it can be used for multi-purpose examinations.

### C. INTENDED USE

The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

### D. SUBSTANTIAL EQUIVALENCE SUMMARY

The Hitachi VERSIFLEX has an indications for use statement that is

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almost identical to that of the legally marketed predicate device. That is, it has the same intended use. The Hitachi VERSIFLEX has the "same technological characteristics" as the predicate devices, and these characteristics are sufficiently precise to assure substantial equivalence.

### TECHNOLOGICAL CHARACTERISTICS E.

The technological characteristics of the Hitachi VERSIFLEX are the same as for the SX-VA30 C-Arm Floroscopic/Angiographic System.

### F. TESTING

The VERSIFLEX is being tested to UL-2601 and will not be marketed until the testing reaches a successful conclusion.

### CONCLUSIONS G.

Hitachi Medical Systems America has demonstrated that the Hitachi VERSIFLEX is substantially equivalent to the Hitachi SX-VA30 Fluoroscopy/Angiography System.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 1999

Hitachi Medical Corporation C/O Whit Athey, Ph.D. Senior Consultant C.L. Macintosh & Associates, Inc. Medical & Regulatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re:

K991231 Hitachi Versiflex Dated: April 12, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR 892.1600/Procode: 90 IZI 21 CFR 892.1650/Procode: 90 JAA

Dear Mr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Indications For Use:

The SF-VA200 is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergman
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K991231

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use