FDA Product Code OEO: Automated Digital Image Manual Interpretation Microscope
The Ihc Her2 Manual Read Of A Digital Slide Application Is Intended For Use As An Aid To The Pathologist In The Detection And Semi-quantitative Measurement Of Her2/neu (c-erbb-2) In Formalin-fixed, Paraffin-embedded Normal And Neoplastic Tissue Immunohistochemically Stained For Her-2 Receptors, Using Microscopy Images Displayed On A Computer Monitor. Her-2 Results Are Indicated For Use As An Aid In The Management, Prognosis And Prediction Of Therapy Outcomes In Breast Cancer.
Leading manufacturers include Aperio Technologies, Olympus America Inc. / Scientific Equipment Group and Philips Medical Systems Nederland B.V..
6
Total
6
Cleared
293d
Avg days
2007
Since
FDA 510(k) Cleared Automated Digital Image Manual Interpretation Microscope Devices (Product Code OEO)
6 devices
Cleared
Jul 16, 2015
Virtuoso System for IHC PR (1E2) using iScan HT
Ventana Medical Systems, Inc.
Pathology
275d
Cleared
Apr 01, 2014
OMNYX IDP FOR HER2 MANUAL APPLICATION
Omnyx, LLC
Pathology
344d
Cleared
Sep 19, 2013
PHILIPS HERCEPTEST DIGITAL SCORE
Philips Medical Systems Nederland B.V.
Pathology
259d
Cleared
Aug 21, 2012
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
Olympus America Inc. / Scientific Equipment Group
Pathology
412d
Cleared
Oct 31, 2008
SCANSCOPE XT SYSTEM
Aperio Technologies
Pathology
274d
Cleared
Dec 28, 2007
SCANSCOPE XT SYSTEM
Aperio Technologies
Pathology
192d