Cleared Traditional

K220582 - ClearCalc Model RADCA V2

K220582 is an FDA 510(k) clearance for ClearCalc Model RADCA V2, 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 174-day FDA review.

K220582 · Radformation, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
174d
Days
Class 2
Risk

K220582 is an FDA 510(k) clearance for the ClearCalc Model RADCA V2. 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 August 22, 2022 after a review of 174 days - an extended review cycle.

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 - K220582

510(k) Number K220582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2022
Decision Date August 22, 2022
Days to Decision 174 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
67d slower than avg
Panel avg: 107d · This submission: 174d
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 147
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K220582.
Oncospace
K222803 · Oncospace, Inc. · Feb 2023
syngo.via RT Image Suite
K220783 · Siemens Medical Solutions USA, Inc. · Sep 2022
MRI Planner
K211841 · Spectronic Medical AB · Aug 2022
Monaco RTP System
K213787 · Elekta Solutions AB · May 2022
RayStation 11B
K220141 · RaySearch Laboratories AB (PUBL) · Apr 2022
INT Contour
K212274 · Carina Medical, LLC · Apr 2022