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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 K972886
Device Name MIRAGE
Applicant
Segami Corp., Inc.
12624 Golden Oak Dr.
Ellicott City,  MD  21042
Applicant Contact PHILIPPE BRIANDET
Correspondent
Segami Corp., Inc.
12624 Golden Oak Dr.
Ellicott City,  MD  21042
Correspondent Contact PHILIPPE BRIANDET
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/05/1997
Decision Date 10/01/1997
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
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