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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 K111824
Device Name FLAT PANEL DETECTOR
Applicant
Canon Inc. -Medical Equipment Group
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
Canon Inc. -Medical Equipment Group
1201 Richardson Dr., Suite 280
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/28/2011
Decision Date 04/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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