# K962100: Volmetric Coincidence Detection System

- Pathway: 510(k) (Traditional)
- Applicant: Elscint, Inc.
- Decided: Jan 10, 1997 after 225 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
No predicates in its family tree.
24 later devices descend from it; 1 cites it directly.
7 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022960: GE Quasar Nuclear Medicine System (2002), 23 descendants of its own
- K093514: Discovery Model NM/CT 670 (2009), 13 descendants of its own
- K153402: Discovery NM/CT 670 CZT (2016), 6 descendants of its own
- K182484: VERITON CT whole body SPECT/CT system (2018), 3 descendants of its own
- K102231: Discovery NM 750B (2010), 3 descendants of its own

Source page: https://510kreport.com/device/K962100
Methodology: https://510kreport.com/methodology