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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 K100837
Device Name PACENTRIC CONNECT, TRAVELER AND WEB
Applicant
Fimreite Software AS
Torggata 26
Horten,  NO 3181
Applicant Contact SVEIN FIMREITE
Correspondent
Fimreite Software AS
Torggata 26
Horten,  NO 3181
Correspondent Contact SVEIN FIMREITE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/24/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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