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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K093809
Device Name VIDAR DENTAL FILM DIGITIZER
Applicant
Vidar Systems Corp.
365 Herndon Pkwy.
Herndon,  VA  20170
Applicant Contact CARRIE L BRANCART
Correspondent
Bsi Healthcare
Kitemark Ct., Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Correspondent Contact JOHN HOWLETT
Regulation Number892.2030
Classification Product Code
LMA  
Date Received12/09/2009
Decision Date 01/07/2010
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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