GENIE PROCESSING AND REVIEW WORKSTATION

K964012 · GE Medical Systems · KPS · Jan 7, 1997 · Radiology

Device Facts

• Record ID: K964012
• Device Name: GENIE PROCESSING AND REVIEW WORKSTATION
• Applicant: GE Medical Systems
• Product Code: KPS · Radiology
• Decision Date: Jan 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data.

Device Story

Genie P&R is a UNIX-based workstation for nuclear medicine image management; inputs include digital image data from nuclear medicine cameras via ethernet network; system performs retrieval, archival, processing, and analysis of images; output displayed on high-resolution color monitor; optional hardcopy via laser/color printer; used by physicians in clinical settings to review diagnostic images; facilitates clinical decision-making by providing tools for image visualization and analysis.

Clinical Evidence

No clinical data provided; device functionality is based on established image processing and management capabilities equivalent to the predicate.

Technological Characteristics

UNIX-based workstation; high-resolution color monitor; keyboard/mouse input; ethernet network connectivity; CD-ROM drive; optional optical disk archive and laser/color hardcopy output.

Indications for Use

Indicated for physicians to display, process, retrieve, and archive nuclear medicine image data acquired from nuclear imaging systems.

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

• Starcam 4000 (K904174)

Submission Summary (Full Text)

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GE Medical Systems

JAN - 9 1997

General Electric Company
P.O. Box 414, Milwaukee, WI 53201

K964012

# SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87 (h).

## Identification Of Submitter

JAN - 7 1997

Submitter:
Larry A. Kroger, Ph.D
GE Medical Systems
3000 N. Grandview Blvd., W-709
Waukesha, WI 53188

Telephone:
[phone]

Fax:
[phone]

Date Of Preparation:
September 30, 1996

## Identification Of The Product

Device Proprietary Name: GENIE Processing And Review Workstation (Genie P&R).
Common Name: Nuclear Medicine Image Workstation
Classification Name: Nuclear Tomography System, 892.1310

Establishment Reg. Number: 2126677
Manufacturing Location: GE Medical Systems
3000 N. Grandview Blvd.
Waukesha, WI 53188

## Marketed Devices

| Predicate Device: | System | Manufacturer | 510(k) # |
| --- | --- | --- | --- |
| | Starcam 4000 | GE Medical Systems | K904174 |

## Device Description

Genie P&R is a computer workstation used for the retrieval, archival, processing, analysis and management of nuclear medicine images (data). It consists of a UNIX based workstation (high resolution color monitor, keyboard, mouse, CD ROM), ethernet network connection and system software. Optional optical disk archive and laser filming/color hardcopy are available.

## Indications For Use

Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data.

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Summary Of Safety And Effectiveness
Genie
Page 2

## Comparison With Predicate Device

Genie P&R and the predicate device can retrieve, archive and process nuclear medicine images. A comparison of the features indicates that Genie P&R has the same intended use as the predicate device. No new safety or effectiveness concerns are raised by the design of Genie P&R.

## Summary Of Studies

Genie P&R can retrieve, archive, process, analyze and manage nuclear medicine images.

## Conclusions

In the opinion of GE Medical Systems, Genie P&R is substantially equivalent to the Starcam 4000 (image processing system only) manufactured by GE Medical Systems (510(k) # K904174). Genie P&R has the same intended use as the predicate device. No new safety or effectiveness concerns are raised by the design of Genie P&R.