Cleared Traditional

AX-700LE AUTOMATIC X-RAY FILM PROCESSOR (K925569) - FDA 510(k) Clearance

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

K925569 · Alphatek Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
73d
Days
Class 2
Risk

K925569 is an FDA 510(k) clearance for the AX-700LE AUTOMATIC X-RAY FILM PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Alphatek Corp. (Chicago, US). The FDA issued a Cleared decision on January 15, 1993 after a review of 73 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 Alphatek Corp. devices

Submission Details

510(k) Number K925569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date January 15, 1993
Days to Decision 73 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 107d · This submission: 73d
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 38
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K925569.
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
K934350 · Eastman Kodak 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
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