Omega Medical Imaging, LLC

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Omega Medical Imaging, LLC on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2025-01-06	K242488	Soteria E-View	Omega Medical Imaging, LLC	Radiology
2021-11-17	K212336	Soteria.AI	Omega Medical Imaging, LLC	Radiology
2019-10-04	K191713	CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)	Omega Medical Imaging, LLC	Radiology

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