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FDA 510(k)

Soteria.AI

K-Number: K212336 · 2021-11-17

ApplicantOmega Medical Imaging, LLC
Decision Date2021-11-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Soteria.AI is a medical device manufactured by Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2021-11-17 under approval number K212336. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soteria.AI?

Soteria.AI is a medical device that received FDA 510(k) clearance on 2021-11-17. It is manufactured by Omega Medical Imaging, LLC. The 510(k) number is K212336.

When was Soteria.AI approved by the FDA?

Soteria.AI received FDA 510(k) clearance on 2021-11-17, under approval number K212336.

What company makes Soteria.AI?

Soteria.AI is manufactured by Omega Medical Imaging, LLC.

What is the FDA product code for Soteria.AI?

The FDA product code for Soteria.AI is OWB.

Other Devices by Omega Medical Imaging, LLC

K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) K182834CS-series-FP with Optional ROI Accessory CA-100S K212890Nyquist.IQ K242488Soteria E-View

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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