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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 K011049
Device Name EXPRESSSUITE
Applicant
Vidar Systems Corp.
460 Spring Park Pl.
Herndon,  VA  20170
Applicant Contact MARY HARP
Correspondent
Vidar Systems Corp.
460 Spring Park Pl.
Herndon,  VA  20170
Correspondent Contact MARY HARP
Regulation Number892.2030
Classification Product Code
LMA  
Date Received04/06/2001
Decision Date 10/01/2001
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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