Cleared Traditional

K925885 - AFP 17 X 4 AUTOMATIC FILM PROCESSOR

K925885 is an FDA 510(k) clearance for AFP 17 X 4 AUTOMATIC FILM PROCESSOR, manufactured by Afp Imaging Corp.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K925885 · Afp Imaging Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
205d
Days
Class 2
Risk

K925885 is an FDA 510(k) clearance for the AFP 17 X 4 AUTOMATIC FILM PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Afp Imaging Corp. (Elmsford, US). The FDA issued a Cleared decision on June 9, 1993 after a review of 205 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 Afp Imaging Corp. devices

FDA 510(k) Submission Details - K925885

510(k) Number K925885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date June 09, 1993
Days to Decision 205 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 107d · This submission: 205d
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 51
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K925885.
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
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
KODAK X-OMAT FS-1A PROCESSOR
K923552 · Eastman Kodak Company · Nov 1992