Cleared Traditional

K960293 - MRTOFLM COMPUTER PROGRAM (FDA 510(k) Clearance)

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

K960293 · Northwest Medical Physics Equipment, Inc. · Radiology device
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Aug 1996
Decision
198d
Days
Class 2
Risk

K960293 is an FDA 510(k) clearance for the MRTOFLM COMPUTER PROGRAM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Northwest Medical Physics Equipment, Inc. (Lynnwood, US). The FDA issued a Cleared decision on August 1, 1996 after a review of 198 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

Submission Details

510(k) Number K960293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date August 01, 1996
Days to Decision 198 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
91d slower than avg
Panel avg: 107d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
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 - IYE Accelerator, Linear, Medical

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