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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K170332
Device Name DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Applicant
Canon, Inc.
9-1, Imaikami-Cho
NAKAHARA-ku, KAWASAKI,  JP 211-8501
Applicant Contact SHINJI MORI
Correspondent
Ken Block Consulting
1201 Richardson Drive, Suite 160
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/02/2017
Decision Date 03/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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