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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 K131106
Device Name DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
Applicant
CANON INC.
1201 RICHARDSON DRIVE,
SUITE 280
RICHARDSON,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
CANON INC.
1201 RICHARDSON DRIVE,
SUITE 280
RICHARDSON,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/19/2013
Decision Date 07/03/2013
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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