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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 K063107
Device Name 3DNET SUITE
Applicant
Biotronics3D, Ltd.
31 Ferry St., Docklands
London,  GB E14 3DT
Applicant Contact HARALAMBOS HATZAKIS
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact PATRICIA L MURPHY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/11/2006
Decision Date 10/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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