GE VISION NUCLEAR MEDICINE WORKSTATION

K012568 · General Electric Co. · KPS · Sep 6, 2001 · Radiology

Device Facts

• Record ID: K012568
• Device Name: GE VISION NUCLEAR MEDICINE WORKSTATION
• Applicant: General Electric Co.
• Product Code: KPS · Radiology
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The GE Vision Nuclear Medicine Workstation is intended for use in the display and analysis of planar and tomographic nuclear medicine images.

Device Story

GE Vision Nuclear Medicine Workstation is a display and analysis system for planar and tomographic nuclear medicine images. Device consists of a PC or UNIX workstation, monitor, keyboard, mouse, modem, and network interface. Operated by clinicians in a clinical environment to view and process medical images. Output assists healthcare providers in clinical decision-making by facilitating image interpretation. Benefits include improved visualization and analysis of nuclear medicine data.

Clinical Evidence

No clinical data. Device evaluated for electrical and radiation safety; conforms to applicable medical device safety standards.

Technological Characteristics

Nuclear medicine image display and processing workstation. Hardware includes PC or UNIX workstation, monitor, keyboard, mouse, modem, and network interface. Operates as a standalone or networked system. Design conforms to 21 CFR 820, ISO 9001, and EN 46001 quality systems.

Indications for Use

Indicated for the display and analysis of planar and tomographic nuclear medicine images in a clinical setting.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• GE Vision POWERstation Nuclear Medicine Workstation (K912573)

Submission Summary (Full Text)

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Special 510(k) Premarket Notification GE Medical Systems - GE Vision Nuclear Medicine Workstation 31-July-2001

K012568

### SEP = 6 2001 Attachment B Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

GE Medical Systems

General Electric Company 8380 Darrow Road, Twinsburg, OH 44087

| Submitter: | GE Medical Systems - SMV<br>8380 Darrow Road<br>Twinsburg, OH 44087 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin Murrock<br>Engineering Technical Services<br>Telephone: [phone]; Fax: [phone] |
| Date Prepared: | 31-July-2001 |
| Device Name: | GE Vision Nuclear Medicine Workstation.<br>Emission Computed Tomography System, 21 CFR 892.1200, 90-KPS |
| Marketed Device: | GE Vision POWERstation Nuclear Medicine Workstation, 510(k) Number K912573,<br>currently in commercial distribution. |
| Device Description: | The GE Vision Nuclear Medicine Workstation is a nuclear medicine image display and<br>processing workstation. It consists of a personal computer (PC) or UNIX workstation,<br>monitor, keyboard, mouse, modem, and network interface. |

### Indications for Use: The GE Vision Nuclear Medicine Workstation is intended for use in the display and analysis of planar and tomographic nuclear medicine images.

Comparison with Predicate Device: The GE Vision Nuclear Medicine Workstation is of a comparable type and substantially equivalent to the currently marketed GE Vision POWERstation Nuclear Medicine Workstation. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, and has the same intended uses as the predicate device.

Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.

Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Vision POWERstation Nuclear Medicine Workstation. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. The the opinion of GE Medical Systems that the GE Vision Nuclear Medicine is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2001

Mr. Kevin M. Murrock Manager, Engineering Technical Services GE Medical Systems General Electric Company 8380 Darrow Road TWINSBURG OH 44087

Re: K012568

GE Vision Nuclear Medicine Workstation (Emission Computed Tomography System) Dated: July 31, 2001 Received: August 9, 2001 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS

#### Dear Mr. Murrock:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we hevice is wbstantially equivalent (for the indications for use stated in the enclosure) to legally marketed in interstate becomments of the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in eccordate with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 If your of root to to to 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 regulation may result in regulatory 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 31 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) prematket 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. B odon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Special 510(k) Premarket Notification GE Medical Systems - GE Vision Nuclear Medicine Workstation 31-July-2001

### STATEMENT OF INTENDED USE

K012568 510(k) Number (if known): __

Device Name: GE Vision Nuclear Medicine Workstation

# Indications for Use

The GE Vision Nuclear Medicine Workstation is intended for use in the display and analysis of planar and tomographic nuclear medicine images.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

OR Over-The-Counter Use_

Nancy Brandon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012568