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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 the device name listed in this FDA 510(k) record. The listed applicant is Radunity Corp.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) 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. The listed applicant is Radunity Corp.. The 510(k) number is K242810.

When did RadUnity (Version 1.0.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for RadUnity (Version 1.0.0)?

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

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

The FDA product code for RadUnity (Version 1.0.0) 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

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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