Cleared Traditional

K942367 - AXT 1400 SPOTFILM DEVICE

K942367 is an FDA 510(k) clearance for AXT 1400 SPOTFILM DEVICE, manufactured by Applied X-Ray Technologies, Inc.. The device is a Class 2 Radiology device with product code IXL cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K942367 · Applied X-Ray Technologies, Inc. · Radiology device
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Jun 1994
Decision
19d
Days
Class 2
Risk

K942367 is an FDA 510(k) clearance for the AXT 1400 SPOTFILM DEVICE. Classified as Device, Spot-film (product code IXL), Class II - Special Controls.

Submitted by Applied X-Ray Technologies, Inc. (Denver, US). The FDA issued a Cleared decision on June 6, 1994 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1670 - 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 Applied X-Ray Technologies, Inc. devices

FDA 510(k) Submission Details - K942367

510(k) Number K942367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1994
Decision Date June 06, 1994
Days to Decision 19 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
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXL Device Classification - Class 2, Special Controls

Product Code IXL Device, Spot-film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1670
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 - IXL Device, Spot-film

All 8
Devices cleared under the same product code (IXL) and FDA review panel - the closest regulatory comparables to K942367.
MD-1835
K964806 · Fischer Imaging Corp. · Mar 1997
ADVANTX 1824 SPOTFILM DEVICE
K950317 · GE Medical Systems · Feb 1995
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
K940386 · Eastman Kodak Company · Aug 1994
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
K924593 · Philips Medical Systems, Inc. · Nov 1992
14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400
K881589 · Continental X-Ray Corp. · Jul 1988
SPOT-FILM DEVICE 8835
K842184 · General Electric Co. · Jul 1984