K Number
K964012
Device Name
GENIE PROCESSING AND REVIEW WORKSTATION
Manufacturer
Date Cleared
1997-01-07

(92 days)

Product Code
Regulation Number
892.1200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
More Information

Not Found

No
The document describes standard image processing and data management functionalities typical of nuclear medicine workstations from that era, with no mention of AI, ML, or related concepts.

No
The device is a computer workstation for processing and displaying medical images for review by physicians, not for direct therapeutic intervention.

No

The device is designed to display, process, and manage data acquired by nuclear medicine cameras for review by physicians. While it aids in the review of medical images, its function is described as processing and displaying acquired data rather than independently making a diagnosis or providing diagnostic interpretations. It is an image processing system, not a diagnostic device itself.

No

The device description explicitly states it consists of a UNIX-based workstation (including hardware components like a monitor, keyboard, mouse, and CD ROM) and optional hardware like an optical disk archive and laser filming/color hardcopy. This indicates it is a hardware and software system, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Genie P&R Function: Genie P&R processes and displays data acquired by nuclear medicine cameras. This data is generated from imaging the patient's body after the administration of a radioactive tracer, not from a sample taken from the body.
  • Intended Use: The intended use is for displaying and processing data from nuclear medicine cameras for review by physicians. This is an imaging processing and management system, not a diagnostic test performed on a biological sample.

Therefore, Genie P&R falls under the category of medical imaging processing and management systems, not in vitro diagnostics.

N/A

Intended Use / 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.

Product codes

Nuclear Tomography System, 892.1310

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.

Mentions image processing

Genie P&R is a computer workstation used for the retrieval, archival, processing, analysis and management of nuclear medicine images (data).

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

nuclear medicine cameras

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K904174

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1200 Emission computed tomography system.

(a)
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.(b)
Classification. Class II.

0

GE Medical Systems

JAN - 9 1997

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

K964012

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) sammary 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:

Telephone: Fax: Date Of Preparation: Larry A. Kroger, Ph.D GE Medical Systems 3000 N. Grandview Blvd., W-709 Waukesha. WI 53188 (414) 544-3894 (414) 544-3863 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:SystemManufacturer510(k) #
Starcam 4000GE Medical SystemsK904174

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.

Image /page/0/Picture/19 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.

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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

. L

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.

i