510(k) K942367

AXT 1400 SPOTFILM DEVICE by Applied X-Ray Technologies, Inc. — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1994
Date Received
May 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type