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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K862416
Device Name FTI 100 MEDICAL THERMAL IMAGER
Applicant
Parexel Intl. Corp.
55 Wheeler St.
Cambridge,  MA  02138
Applicant Contact SAYIGH, PHD
Correspondent
Parexel Intl. Corp.
55 Wheeler St.
Cambridge,  MA  02138
Correspondent Contact SAYIGH, PHD
Regulation Number892.2040
Classification Product Code
LMC  
Date Received06/25/1986
Decision Date 07/01/1986
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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