# K964012: Genie Processing and Review Workstation

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 7, 1997 after 92 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904174 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904174: Starcam 4000, General Electric Co. (1991) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K964012
Methodology: https://510kreport.com/methodology