Cleared Traditional

ClearCalc Model RADCA V2.6

K252863 · Radformation, Inc. · Radiology
Dec 2025
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K252863 is an FDA 510(k) clearance for the ClearCalc Model RADCA V2.6, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Radformation, Inc. (New York, US). The FDA issued a Cleared decision on December 19, 2025, 101 days after receiving the submission on September 9, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K252863 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2025
Decision Date December 19, 2025
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050