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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K060505
Device Name VOXAR 3D ENTERPRISE, MODEL 6.1
Applicant
Barcoview Mis Edinburgh
Bonnington Bond, 2 Anderson Pl
Edinburgh, Lothian,  GB EH6 5NP
Applicant Contact NEIL PHILLIPS
Correspondent
Barcoview Mis Edinburgh
Bonnington Bond, 2 Anderson Pl
Edinburgh, Lothian,  GB EH6 5NP
Correspondent Contact NEIL PHILLIPS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/27/2006
Decision Date 03/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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