Cleared Traditional

AXT 150M MANUAL COLLIMATOR (AXT 150M)

K972966 · Applied X-Ray Technologies, Inc. · Radiology

Aug 1997

Decision

10d

Days

Class 2

Risk

About This 510(k) Submission

K972966 is an FDA 510(k) clearance for the AXT 150M MANUAL COLLIMATOR (AXT 150M), a Collimator, Manual, Radiographic (Class II — Special Controls, product code IZX), submitted by Applied X-Ray Technologies, Inc. (Denver, US). The FDA issued a Cleared decision on August 21, 1997, 10 days after receiving the submission on August 11, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number	K972966 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 1997
Decision Date	August 21, 1997
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement