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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K070563
Device Name VIDAR VISION 2000
Applicant
Vidar Systems Corp.
75 Orchard Spring Ests
Waterbury,  VT  05676
Applicant Contact JAMES M TAYLOR
Correspondent
Bsi Healthcare
Kitemark Ct., Davy Ave.
Knowlhill
Milton Keynes,  GB MK5 8PP
Correspondent Contact JOHN HOWLETT
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/27/2007
Decision Date 03/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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