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FDA 510(k)

ClearCalc Model RADCA V2.6

K-Number: K252863 · 2025-12-19

Decision Date2025-12-19
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearCalc Model RADCA V2.6 is a medical device manufactured by Radformation, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval number K252863. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearCalc Model RADCA V2.6?

ClearCalc Model RADCA V2.6 is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Radformation, Inc.. The 510(k) number is K252863.

When was ClearCalc Model RADCA V2.6 approved by the FDA?

ClearCalc Model RADCA V2.6 received FDA 510(k) clearance on 2025-12-19, under approval number K252863.

What company makes ClearCalc Model RADCA V2.6?

ClearCalc Model RADCA V2.6 is manufactured by Radformation, Inc..

What is the FDA product code for ClearCalc Model RADCA V2.6?

The FDA product code for ClearCalc Model RADCA V2.6 is MUJ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.