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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K162052
Device Name Sentinella 102, Sentinella 102 Horus
Applicant
General Equipment For Medical Imaging (Oncovision-
Eduardo Primo Yufera, N 3
Valencia,  ES 46012
Applicant Contact JOSE MONTES
Correspondent
General Equipment For Medical Imaging (Oncovision-
Eduardo Primo Yufera, N 3
Valencia,  ES 46012
Correspondent Contact JOSE MONTES
Regulation Number892.1100
Classification Product Code
IYX  
Date Received07/25/2016
Decision Date 08/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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