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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 K071584
Device Name OASIS RELEASE 1.0
Applicant
Segami Corporation
8325 Guilford Rd., Suite B
Columbia,  MD  21046
Applicant Contact PHILIPPE BRIANDET
Correspondent
Segami Corporation
8325 Guilford Rd., Suite B
Columbia,  MD  21046
Correspondent Contact PHILIPPE BRIANDET
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/11/2007
Decision Date 08/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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