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FDA 510(k)

MD.ai Viewer

K-Number: K223425 · 2023-02-10

ApplicantMdai, Inc.
Decision Date2023-02-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MD.ai Viewer is a medical device manufactured by Mdai, Inc.. It received FDA 510(k) clearance on 2023-02-10 under approval number K223425. 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 MD.ai Viewer?

MD.ai Viewer is a medical device that received FDA 510(k) clearance on 2023-02-10. It is manufactured by Mdai, Inc.. The 510(k) number is K223425.

When was MD.ai Viewer approved by the FDA?

MD.ai Viewer received FDA 510(k) clearance on 2023-02-10, under approval number K223425.

What company makes MD.ai Viewer?

MD.ai Viewer is manufactured by Mdai, Inc..

What is the FDA product code for MD.ai Viewer?

The FDA product code for MD.ai Viewer is LLZ.

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Official Source

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