Cleared Traditional

A.X.T. SPOTFILM DEVICE

K882492 · Applied X-Ray Technologies, Inc. · Radiology

Jul 1988

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K882492 is an FDA 510(k) clearance for the A.X.T. SPOTFILM DEVICE, a Device, Spot-film (Class II — Special Controls, product code IXL), submitted by Applied X-Ray Technologies, Inc. (Westminster, US). The FDA issued a Cleared decision on July 21, 1988, 35 days after receiving the submission on June 16, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number	K882492 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 1988
Decision Date	July 21, 1988
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—