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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 K091435
Device Name DIGITAL RADIOGRAPHY MODEL CXDI-55G
Applicant
CANON INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042
Applicant Contact SHEILA DRISCOLL
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/14/2009
Decision Date 05/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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