Cleared Traditional

K923554 - KODAK EKTASCAN

K923554 is the FDA 510(k) clearance for KODAK EKTASCAN by Eastman Kodak Company. It is a Class 2 Radiology device (product code IXW) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K923554 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
210d
Days
Class 2
Risk

K923554 is an FDA 510(k) clearance for the KODAK EKTASCAN. 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 February 12, 1993 after a review of 210 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 K923554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date February 12, 1993
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
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 42
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K923554.
FUJI MEDICAL FILM PROCESSOR FPM2800
K935957 · Fujifilm Medical System U.S.A., Inc. · Jan 1994
KODAK XML 300 DARKROOM FILM FEEDER
K933001 · Eastman Kodak Company · Sep 1993
FUJI DAYLIGHT CASSETTE MULTI-LOADER
K933408 · Fujifilm Medical System U.S.A., Inc. · Aug 1993
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)
K924552 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1992
KODAK X-OMAT FS-1A PROCESSOR
K923552 · Eastman Kodak Company · Nov 1992
KODAK X-OMAT MODEL 180 LP PROCESSOR
K921269 · Eastman Kodak Company · May 1992