Cleared Traditional

K962750 - 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR

K962750 is an FDA 510(k) clearance for 3M TRIMATIC MODULAR ADVANCED PROCESSING..., manufactured by Imation Corp.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K962750 · Imation Corp. · Radiology device
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Aug 1996
Decision
37d
Days
Class 2
Risk

K962750 is an FDA 510(k) clearance for the 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROC.... Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Imation Corp. (Oakdale, US). The FDA issued a Cleared decision on August 21, 1996 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imation Corp. devices

FDA 510(k) Submission Details - K962750

510(k) Number K962750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date August 21, 1996
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - IXW Processor, Radiographic-film, Automatic

All 44
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K962750.
FREEDOM AUTOMATIC FILM PROCESSOR
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K951373 · Fujifilm Medical System U.S.A., Inc. · Oct 1995
KODAK AUTOMIXER II PLUS
K954484 · Eastman Kodak Company · Oct 1995
KODAK X-OMAT 3000 RA PROCESSOR
K951396 · Eastman Kodak Company · May 1995