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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 K992547
Device Name CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
Applicant
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Applicant Contact KEN SHADOFF
Correspondent
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Correspondent Contact KEN SHADOFF
Regulation Number892.1680
Classification Product Code
MQB  
Date Received07/30/1999
Decision Date 10/13/1999
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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