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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 K081648
Device Name DIGITAL RADIOGRAPHY CXDI-60G
Applicant
Canon, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Applicant Contact SHEILA DRISCOLL
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/12/2008
Decision Date 06/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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