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FDA 510(k)

OmegaAI Image Viewer

K-Number: K222476 · 2022-11-17

ApplicantRamsoft, Inc.
Decision Date2022-11-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OmegaAI Image Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Ramsoft, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K222476. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmegaAI Image Viewer?

OmegaAI Image Viewer is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Ramsoft, Inc.. The 510(k) number is K222476.

When did OmegaAI Image Viewer receive FDA 510(k) clearance?

OmegaAI Image Viewer received FDA 510(k) clearance on 2022-11-17, under 510(k) number K222476.

Who is the listed applicant for OmegaAI Image Viewer?

The FDA 510(k) record lists Ramsoft, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmegaAI Image Viewer?

The FDA product code for OmegaAI Image Viewer is LLZ.

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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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