Cleared Traditional

K022961 - RTDOSEPLAN

K022961 is an FDA 510(k) clearance for RTDOSEPLAN, manufactured by Math Resolutions, LLC. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K022961 · Math Resolutions, LLC · Radiology device
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Jan 2003
Decision
147d
Days
Class 2
Risk

K022961 is an FDA 510(k) clearance for the RTDOSEPLAN. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Math Resolutions, LLC (Columbia, US). The FDA issued a Cleared decision on January 31, 2003 after a review of 147 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 Math Resolutions, LLC devices

FDA 510(k) Submission Details - K022961

510(k) Number K022961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date January 31, 2003
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 107d · This submission: 147d
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 213
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K022961.
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K032724 · Adac Laboratories · Oct 2003
NOMOS CORVUS 5.0M
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OTP 1.2
K031349 · Nucletron Corp. · Aug 2003
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · Siemens Medical Solutions USA, Inc. · Nov 2002
SPOT PRO (220V), MODEL 131.099
K022741 · Nucletron Corporation · Oct 2002
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · Computerized Medical Systems, Inc. · Oct 2002