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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 K060433
Device Name DIGITAL RADIOGRAPHY CXDI-50C
Applicant
CANON INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042
Applicant Contact SHEILA DRISCOLL
Correspondent
BSI HEALTHCARE
KITEMARK COURT, DAVY AVENUE
KNOWLHILL
MILTON KEYNES,  GB MK5 8PP
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/21/2006
Decision Date 03/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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