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FDA 510(k)

RadAlly

K-Number: K213660 · 2023-03-31

ApplicantImaging Wave, LLC
Decision Date2023-03-31
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadAlly is a medical device manufactured by Imaging Wave, LLC. It received FDA 510(k) clearance on 2023-03-31 under approval number K213660. 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 RadAlly?

RadAlly is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Imaging Wave, LLC. The 510(k) number is K213660.

When was RadAlly approved by the FDA?

RadAlly received FDA 510(k) clearance on 2023-03-31, under approval number K213660.

What company makes RadAlly?

RadAlly is manufactured by Imaging Wave, LLC.

What is the FDA product code for RadAlly?

The FDA product code for RadAlly is LLZ.

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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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