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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 K073306
Device Name XORANCONNECT
Applicant
XORAN TECHNOLOGIES, INC.
309 N. FIRST STREET
ANN ARBOR,  MI  48103 -3301
Applicant Contact AMY S KIM
Correspondent
XORAN TECHNOLOGIES, INC.
309 N. FIRST STREET
ANN ARBOR,  MI  48103 -3301
Correspondent Contact AMY S KIM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/23/2007
Decision Date 01/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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