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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Intensifying, Radiographic
510(k) Number K862414
Device Name FUJI CR IMAGING PLATE
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 Number892.1960
Classification Product Code
EAM  
Date Received06/25/1986
Decision Date 02/26/1987
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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