Cleared Traditional

K954484 - KODAK AUTOMIXER II PLUS

K954484 is an FDA 510(k) clearance for KODAK AUTOMIXER II PLUS, 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 21-day FDA review.

K954484 · Eastman Kodak Company · Radiology device
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Oct 1995
Decision
21d
Days
Class 2
Risk

K954484 is an FDA 510(k) clearance for the KODAK AUTOMIXER II PLUS. 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 October 18, 1995 after a review of 21 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K954484

510(k) Number K954484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date October 18, 1995
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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 K954484.
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
K962750 · Imation Corp. · Aug 1996
JPI AUTOMATIC X-RAY FILM PROCESSOR
K955706 · Jpi Healthcare Co, Ltd. · Feb 1996
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ
K951373 · Fujifilm Medical System U.S.A., Inc. · Oct 1995
KODAK X-OMAT 3000 RA PROCESSOR
K951396 · Eastman Kodak Company · May 1995
KODAK X-OMAT 5000 RA PROCESSOR
K951397 · Eastman Kodak Company · May 1995
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K944046 · Fujifilm Medical System U.S.A., Inc. · May 1995