# K974444: Numastation

- Pathway: 510(k) (Traditional)
- Applicant: Numa, Inc.
- Decided: Feb 13, 1998 after 80 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 K923736 (1992). 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)
- K923736: Gamma 600T, Strichman Medical Equipment, Inc. (1992) Summary page 2.

## Indications for use
The NumaStation is a stand-alone computer interface that connects to third party gamma cameras and acquires data and transfers that data to a processing computer; it is used in planar and whole-body and SPECT imaging.

Source page: https://510kreport.com/device/K974444
Methodology: https://510kreport.com/methodology