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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 K082441
Device Name NORDICICE SOFTWARE
Applicant
Nordicimaginglab AS
Mollendalsveien 65c
Bergen, Hordaland,  NO 5009
Applicant Contact STIAN SCISLY SAGEVIK
Correspondent
Nordicimaginglab AS
Mollendalsveien 65c
Bergen, Hordaland,  NO 5009
Correspondent Contact STIAN SCISLY SAGEVIK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/25/2008
Decision Date 11/21/2008
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
Recalls CDRH Recalls
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