Company profile

Omega Medical Imaging, LLC

Omega Medical Imaging, LLC has 3 AI-enabled medical devices on the FDA list. The first decision was on October 4, 2019 and the most recent on January 6, 2025 (Soteria E-View). Its most common review panel is Radiology (3 devices).

3AI devices

2019First decision

2025Latest decision

1Specialties

Per year

201920212025

Omega Medical Imaging, LLC AI devices per year: 2019 1, 2021 1, 2025 1

By specialty

Radiology3

Related guides

Top radiology devices

Timeline

January 6, 2025 · 510(k) K242488Soteria E-View · Radiology · JAA
November 17, 2021 · 510(k) K212336Soteria.AI · Radiology · OWB
October 4, 2019 · 510(k) K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) · Radiology · JAA