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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 K103591
Device Name DIGITAL RADIOGRAPHY
Applicant
Canon Inc. -Medical Equipment Group
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
Canon Inc. -Medical Equipment Group
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/07/2010
Decision Date 03/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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