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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 K010726
Device Name MODIFICATION TO MIRAGE
Applicant
Segami Corp., Inc.
8335 Guilford Rd.
Suite I
Columbia,  MD  21046
Applicant Contact PHILIPPE A BRIANDET
Correspondent
Segami Corp., Inc.
8335 Guilford Rd.
Suite I
Columbia,  MD  21046
Correspondent Contact PHILIPPE A BRIANDET
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/12/2001
Decision Date 04/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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