# K911454: FC2000

- Pathway: 510(k) (Traditional)
- Applicant: S & S Inficon, Inc.
- Decided: Jul 15, 1991 after 103 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, 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/K911454
Methodology: https://510kreport.com/methodology