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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 K023586
Device Name DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
Applicant
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact SHIELA DRISCOLL
Correspondent
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Correspondent Contact SHIELA DRISCOLL
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/25/2002
Decision Date 11/05/2002
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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