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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 K933632
Device Name MEDSCAN 12
Applicant
Vidar Systems Corp.
Truvel Division
520 D Herndon Pkwy.
Herndon,  VA  22070
Applicant Contact CHARLES R COLEMAN
Correspondent
Vidar Systems Corp.
Truvel Division
520 D Herndon Pkwy.
Herndon,  VA  22070
Correspondent Contact CHARLES R COLEMAN
Regulation Number892.2030
Classification Product Code
LMA  
Date Received07/27/1993
Decision Date 12/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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