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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 K981556
Device Name CANON X-RAY DIGITAL CAMERA CXDI-11
Applicant
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Applicant Contact GLENN IMPAL
Correspondent
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Correspondent Contact GLENN IMPAL
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/01/1998
Decision Date 11/04/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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