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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 a medical device manufactured by Ramsoft, Inc.. It received FDA 510(k) clearance on 2022-11-17 under approval 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. It is manufactured by Ramsoft, Inc.. The 510(k) number is K222476.

When was OmegaAI Image Viewer approved by the FDA?

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

What company makes OmegaAI Image Viewer?

OmegaAI Image Viewer is manufactured by Ramsoft, Inc..

What is the FDA product code for OmegaAI Image Viewer?

The FDA product code for OmegaAI Image Viewer is LLZ.

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Official Source

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