# K212336: Soteria.AI

- Pathway: 510(k) (Traditional)
- Applicant: Omega Medical Imaging, LLC
- Decided: Nov 17, 2021 after 113 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- 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: 10 generations back to K912470 (1991). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182834: CS-series-FP with Optional ROI Accessory CA-100S, Omega Medical Imaging, LLC (2019) Summary page 5.

## Most influential descendants
- K242488: Soteria E-View (2025), 0 descendants of its own

## Indications for use
The System is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic and interventional x-ray imaging for General and Pediatric Populations

Source page: https://510kreport.com/device/K212336
Methodology: https://510kreport.com/methodology