Cleared Traditional

PREFERENCE TREATMENT SYSTEM (K983793) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983793 · Northwest Medical Physics Equipment, Inc. · Radiology device
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Oct 1999
Decision
343d
Days
Class 2
Risk

K983793 is an FDA 510(k) clearance for the PREFERENCE TREATMENT SYSTEM. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Northwest Medical Physics Equipment, Inc. (Lynnwood, US). The FDA issued a Cleared decision on October 5, 1999 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K983793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1998
Decision Date October 05, 1999
Days to Decision 343 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
236d slower than avg
Panel avg: 107d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 475
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K983793.
VENTRICULAR ANALYSIS TOOLKIT OPTION
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INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
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QUANTITATIVE FLOW
K992225 · Philips Medical Systems (Cleveland), Inc. · Sep 1999
MRGP OPTICAL TRACKING UNIT
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IPASS BOLUS TRACKING
K992412 · Philips Medical Systems (Cleveland), Inc. · Aug 1999