Cleared Traditional

X-RAY FILM PROCESSOR (K940112) - FDA 510(k) Clearance

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

K940112 · Fischer Industries, Inc. · Radiology device
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Apr 1995
Decision
456d
Days
Class 2
Risk

K940112 is an FDA 510(k) clearance for the X-RAY FILM PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Fischer Industries, Inc. (Geneva, US). The FDA issued a Cleared decision on April 11, 1995 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Fischer Industries, Inc. devices

Submission Details

510(k) Number K940112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date April 11, 1995
Days to Decision 456 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
349d slower than avg
Panel avg: 107d · This submission: 456d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K940112.
KODAK AUTOMIXER II PLUS
K954484 · Eastman Kodak Company · Oct 1995
KODAK X-OMAT 3000 RA PROCESSOR
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KODAK X-OMAT 5000 RA PROCESSOR
K951397 · Eastman Kodak Company · May 1995
3M XP-2000 X-RAY FILM PROCESSOR
K940558 · 3M Company · Mar 1994
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
K934350 · Eastman Kodak Company · Mar 1994
KODAK XML 300 DARKROOM FILM FEEDER
K933001 · Eastman Kodak Company · Sep 1993