510(k) · Radiology

Soteria.AI

by Omega Medical Imaging, LLC

Soteria.AI is an AI-enabled medical device from Omega Medical Imaging, LLC that the U.S. FDA cleared through 510(k) K212336 on November 17, 2021. Its lead review panel is Radiology and its primary product code is OWB (Interventional Fluoroscopic X-Ray System).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK212336
Pathway510(k)
Date of final decision
Company (FDA list)Omega Medical Imaging, LLC
Lead review panelRadiology
Primary product codeOWB — Interventional Fluoroscopic X-Ray System
Applicant (openFDA)Omega Medical Imaging, LLC
Applicant locationSanford, FL, US
Device classClass 2
Regulation number21 CFR 892.1650
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Soteria.AI went through this pathway (K212336).

openFDA lists it as a Class 2 device under 21 CFR 892.1650. Class II devices are moderate risk and are subject to general and special controls.

Product code OWB covers 15 devices on the FDA AI list. By decision date, this device is #3 of 15 under that code. Omega Medical Imaging, LLC has 3 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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