Cleared Traditional

AXT 1400 SPOTFILM DEVICE

K942367 · Applied X-Ray Technologies, Inc. · Radiology

Jun 1994

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K942367 is an FDA 510(k) clearance for the AXT 1400 SPOTFILM DEVICE, a Device, Spot-film (Class II — Special Controls, product code IXL), submitted by Applied X-Ray Technologies, Inc. (Denver, US). The FDA issued a Cleared decision on June 6, 1994, 19 days after receiving the submission on May 18, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number	K942367 FDA.gov
FDA Decision	Cleared 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