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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 K003484
Device Name NETRA WORKSTATION AND NETRAMD SOFTWARE
Applicant
Scimage, Inc.
4916 El Camino Real, Suite 200
Los Altos,  CA  94022
Applicant Contact MICHAEL PETER
Correspondent
Scimage, Inc.
4916 El Camino Real, Suite 200
Los Altos,  CA  94022
Correspondent Contact MICHAEL PETER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/09/2000
Decision Date 01/19/2001
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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