Cleared Traditional

K933001 - KODAK XML 300 DARKROOM FILM FEEDER

K933001 is an FDA 510(k) clearance for KODAK XML 300 DARKROOM FILM FEEDER, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K933001 · Eastman Kodak Company · Radiology device
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Sep 1993
Decision
99d
Days
Class 2
Risk

K933001 is an FDA 510(k) clearance for the KODAK XML 300 DARKROOM FILM FEEDER. 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 September 28, 1993 after a review of 99 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K933001

510(k) Number K933001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1993
Decision Date September 28, 1993
Days to Decision 99 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
8d faster than avg
Panel avg: 107d · This submission: 99d
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 50
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K933001.
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
FUJI MEDICAL FILM PROCESSOR FPM2800
K935957 · Fujifilm Medical System U.S.A., Inc. · Jan 1994
FUJI DAYLIGHT CASSETTE MULTI-LOADER
K933408 · Fujifilm Medical System U.S.A., Inc. · Aug 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