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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 K051494
Device Name MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
Applicant
Cr Tech, Ltd.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Applicant Contact LEONARD FRIER
Correspondent
Cr Tech, Ltd.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Correspondent Contact LEONARD FRIER
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/06/2005
Decision Date 09/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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