Cleared Traditional

K193640 - ClearCalc

K193640 is the FDA 510(k) clearance for ClearCalc by Radformation, Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K193640 · Radformation, Inc. · Radiology device
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Apr 2020
Decision
104d
Days
Class 2
Risk

K193640 is an FDA 510(k) clearance for the ClearCalc. 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 April 9, 2020 after a review of 104 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

Submission Details

510(k) Number K193640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2019
Decision Date April 09, 2020
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 127
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K193640.
Eclipse Treatment Planning System v16.1
K201607 · Varian Medical Systems, Inc. · Jul 2020
RayCare 3.1
K200487 · RaySearch Laboratories AB (PUBL) · Jun 2020
Panther Stereotactic
K193459 · Prowess, Inc. · Apr 2020
Eclipse Treatment Planning System v16.0
K200608 · Varian Medical Systems, Inc. · Apr 2020
MRCAT brain
K193109 · Philips Medical Systems MR Finland · Jan 2020
RadCalc Software
K193381 · Lifeline Software, Inc. · Dec 2019