FDA 510(k) Applications for Medical Device Product Code "OEO"
(Automated Digital Image Manual Interpretation Microscope)

FDA 510(k) Number Applicant Device Name Decision Date
K080254 APERIO TECHNOLOGIES SCANSCOPE XT SYSTEM 10/31/2008
K071671 APERIO TECHNOLOGIES SCANSCOPE XT SYSTEM 12/28/2007
K111914 OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM 08/21/2012
K131140 OMNYX, LLC OMNYX IDP FOR HER2 MANUAL APPLICATION 04/01/2014
K130021 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS HERCEPTEST DIGITAL SCORE 09/19/2013
K142965 Ventana Medical Systems, Inc. Virtuoso System for IHC PR (1E2) using iScan HT 07/16/2015


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