Cleared Traditional

K012575 - PREFERNCE IMRT TREATMENT PLANNING MODULE

K012575 is an FDA 510(k) clearance for PREFERNCE IMRT TREATMENT PLANNING MODULE, manufactured by Northwest Medical Physics Equipment, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K012575 · Northwest Medical Physics Equipment, Inc. · Radiology device
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Mar 2002
Decision
215d
Days
Class 2
Risk

K012575 is an FDA 510(k) clearance for the PREFERNCE IMRT TREATMENT PLANNING MODULE. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Northwest Medical Physics Equipment, Inc. (Lynnwood, US). The FDA issued a Cleared decision on March 12, 2002 after a review of 215 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 Northwest Medical Physics Equipment, Inc. devices

FDA 510(k) Submission Details - K012575

510(k) Number K012575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2001
Decision Date March 12, 2002
Days to Decision 215 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 107d · This submission: 215d
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 162
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K012575.
FOCUS RADIATION TREATMENT PLANNING SYSTEM
K020027 · Computerized Medical Systems, Inc. · Oct 2002
ACQPLAN 5.0
K013644 · Philips Medical Systems, Inc. · Sep 2002
ECLIPSE, HELIOS OPTION
K021268 · Varian Medical Systems, Inc. · May 2002
FOCAL SIM
K013112 · Computerized Medical Systems, Inc. · Dec 2001
VARISEED 7.0
K012017 · Varian Medical Systems · Jul 2001
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K010784 · Nucletron Corp. · Apr 2001