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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 the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Imaging, LLC. It received FDA 510(k) clearance on 2021-11-17 under 510(k) 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. The listed applicant is Omega Medical Imaging, LLC. The 510(k) number is K212336.

When did Soteria.AI receive FDA 510(k) clearance?

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

Who is the listed applicant for Soteria.AI?

The FDA 510(k) record lists Omega Medical Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Soteria.AI?

The FDA product code for Soteria.AI is OWB.

Other records listing Omega Medical Imaging, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242488Soteria E-ViewK212890Nyquist.IQK191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)K182834CS-series-FP with Optional ROI Accessory CA-100SK171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System

Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

Official Source

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

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