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510(k) K153119

Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, by Summit Industries, LLC — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2016
Date Received
October 29, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Summit Industries, LLC

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  • K874908 — C900 X-RAY FILM PROCESSOR (February 12, 1988)
  • K874687 — COLLI-MATETM MODEL NO. B800 (December 30, 1987)
  • K851440 — RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR (June 5, 1985)
  • K850198 — FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG (May 14, 1985)
  • K850118 — XMA INTEGRATED TABLE (April 9, 1985)
  • K850117 — XMA 325 (X-RAY GENERATOR) (April 9, 1985)

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