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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 K130636
Device Name TELERADPRO EDGE; TELERADPRO EDGE HD-CCD
Applicant
Vidar Systems Corp.
365 Herndon Pkwy.
Herndon,  VA  20170
Applicant Contact CARRIE L BRANCART
Correspondent
Vidar Systems Corp.
365 Herndon Pkwy.
Herndon,  VA  20170
Correspondent Contact CARRIE L BRANCART
Regulation Number892.2030
Classification Product Code
LMA  
Date Received03/11/2013
Decision Date 06/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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