# K050692: FLXIS

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Apr 8, 2005 after 22 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
Longest line of descent: 3 generations back to K912470 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032046: Phillips Omnidiagnost Eleva, Philips Medical Systems, Inc. (2003) Summary page 1.

## Indications for use
FLXIS is intended to visualize anatomical structures by converting a pattern of X-radiation into a visible image through electronic amplification.

Source page: https://510kreport.com/device/K050692
Methodology: https://510kreport.com/methodology