AXT 150M MANUAL COLLIMATOR (AXT 150M)— 510(k) K972966

Name: FDA 510(k) clearance K972966
Creator: U.S. Food and Drug Administration
Published: 1997-08-21

Substantially Equivalent

Applied X-Ray Technologies, Inc.

FDA 510(k) clearance K972966 for AXT 150M MANUAL COLLIMATOR (AXT 150M), Substantially Equivalent on 1997-08-21. Applicant: Applied X-Ray Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Applied X-Ray Technologies, Inc.
Product code: Code IZX
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 1997-08-11
Decision date: 1997-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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