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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K043441
Device Name MIRAGE, RELEASE 5.5
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 Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
LLZ  
Date Received12/14/2004
Decision Date 01/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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