510(k) K972966

AXT 150M MANUAL COLLIMATOR (AXT 150M) by Applied X-Ray Technologies, Inc. — Product Code IZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1997
Date Received
August 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collimator, Manual, Radiographic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type