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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 K993599
Device Name DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
Applicant
Vidar Systems Corp.
460 Spring Park Pl.
Herndon,  VA  20170
Applicant Contact MARY "PENNIE" DRINKARD
Correspondent
Vidar Systems Corp.
460 Spring Park Pl.
Herndon,  VA  20170
Correspondent Contact MARY "PENNIE" DRINKARD
Regulation Number892.2030
Classification Product Code
LMA  
Date Received10/25/1999
Decision Date 01/18/2000
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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