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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 K031447
Device Name CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
Applicant
CANON INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042
Applicant Contact SHEILA DRISCOLL
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/07/2003
Decision Date 05/21/2003
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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