Cleared Traditional

KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS (K934350) - FDA 510(k) Clearance

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

K934350 · Eastman Kodak Company · Radiology device
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Mar 1994
Decision
195d
Days
Class 2
Risk

K934350 is an FDA 510(k) clearance for the KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 21, 1994 after a review of 195 days - an extended review 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: 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 Eastman Kodak Company devices

Submission Details

510(k) Number K934350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date March 21, 1994
Days to Decision 195 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 107d · This submission: 195d
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 37
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K934350.
KODAK X-OMAT 3000 RA PROCESSOR
K951396 · Eastman Kodak Company · May 1995
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 XML 300 DARKROOM FILM FEEDER
K933001 · Eastman Kodak Company · Sep 1993
KODAK EKTASCAN
K923554 · Eastman Kodak Company · Feb 1993
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
K924552 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1992