Cleared Special

K193381 - RadCalc Software

K193381 is the FDA 510(k) clearance for RadCalc Software by Lifeline Software, Inc.. It is a Class 2 Radiology device (product code MUJ) cleared through the Special 510(k) pathway after a 26-day FDA review.

K193381 · Lifeline Software, Inc. · Radiology device
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Dec 2019
Decision
26d
Days
Class 2
Risk

K193381 is an FDA 510(k) clearance for the RadCalc Software. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Lifeline Software, Inc. (Tyler, US). The FDA issued a Cleared decision on December 31, 2019 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Lifeline Software, Inc. devices

Submission Details

510(k) Number K193381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2019
Decision Date December 31, 2019
Days to Decision 26 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 123
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K193381.
ClearCalc
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