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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 K090546
Device Name MODIFICATION TO NORDICICE SOFTWARE
Applicant
Nordicimaginglab AS
Mollendalsveien 65c
Bergen, Hordaland,  NO 5009
Applicant Contact CHANDANA G BHANDARI
Correspondent
Nordicimaginglab AS
Mollendalsveien 65c
Bergen, Hordaland,  NO 5009
Correspondent Contact CHANDANA G BHANDARI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/02/2009
Decision Date 06/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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