Cleared Traditional

K252863 - ClearCalc Model RADCA V2.6

K252863 is an FDA 510(k) clearance for ClearCalc Model RADCA V2.6, manufactured by Radformation, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K252863 · Radformation, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
101d
Days
Class 2
Risk

K252863 is an FDA 510(k) clearance for the ClearCalc Model RADCA V2.6. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Radformation, Inc. (New York, US). The FDA issued a Cleared decision on December 19, 2025 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radformation, Inc. devices

FDA 510(k) Submission Details - K252863

510(k) Number K252863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 144
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K252863.
TrueFit Bolus
K260308 · Adaptiiv Medical Technologies, Inc. · Feb 2026
ART-Plan+ (v3.1.0)
K253091 · Therapanacea Sas · Dec 2025
RayStation (2024A SP3)
K252109 · RaySearch Laboratories AB (PUBL) · Dec 2025
PlanOne 1
K250963 · Cosylab Jsc, Control System Laboratory · Nov 2025
Dose+ (1.0)
K250064 · Mvision AI OY · Sep 2025
RT Elements (4.5)
K250440 · Brainlab AG · Jun 2025