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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 K062221
Device Name CXDI-40EC
Applicant
Canon, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact SHEILA DRISCOLL
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact JEFFREY D RONGERO
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/02/2006
Decision Date 08/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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