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FDA 510(k)

RadUnity (Version 1.0.0)

K-Number: K242810 · 2024-11-26

ApplicantRadunity Corp.
Decision Date2024-11-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RadUnity (Version 1.0.0) is a medical device manufactured by Radunity Corp.. It received FDA 510(k) clearance on 2024-11-26 under approval number K242810. 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 RadUnity (Version 1.0.0)?

RadUnity (Version 1.0.0) is a medical device that received FDA 510(k) clearance on 2024-11-26. It is manufactured by Radunity Corp.. The 510(k) number is K242810.

When was RadUnity (Version 1.0.0) approved by the FDA?

RadUnity (Version 1.0.0) received FDA 510(k) clearance on 2024-11-26, under approval number K242810.

What company makes RadUnity (Version 1.0.0)?

RadUnity (Version 1.0.0) is manufactured by Radunity Corp..

What is the FDA product code for RadUnity (Version 1.0.0)?

The FDA product code for RadUnity (Version 1.0.0) is LLZ.

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Official Source

View on FDA Database →

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