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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 St.
Ann Arbor,  MI  48103 -3301
Applicant Contact AMY S KIM
Correspondent
Xoran Technologies, Inc.
309 N. First St.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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