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510(k) K173823

Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System by Summit Industries, LLC — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2018
Date Received
December 18, 2017
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

  • K153119 — Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiog (March 14, 2016)
  • 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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