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510(k) K882492

A.X.T. SPOTFILM DEVICE by Applied X-Ray Technologies, Inc. — Product Code IXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1988
Date Received
June 16, 1988
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

Other clearances by Applied X-Ray Technologies, Inc.

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  • K881589 — 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 (July 18, 1988)
  • K842184 — SPOT-FILM DEVICE 8835 (July 17, 1984)