# K963037: Patriot

- Pathway: 510(k) (Traditional)
- Applicant: Infimed, Inc.
- Decided: Sep 27, 1996 after 53 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 4 cite it directly.
0 of 42 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
- K012490: Orion Digital Imaging System (2002), 33 descendants of its own
- K093066: I5 Digital X-Ray Imaging System, Model I5 (2010), 22 descendants of its own
- K103416: Nexus DRF Digital X-Ray Imaging System (2011), 17 descendants of its own
- K130318: Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) (2013), 15 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own

Source page: https://510kreport.com/device/K963037
Methodology: https://510kreport.com/methodology