Automated Digital Image Manual Interpretation Microscope
Hematology · 21 CFR 864.1860
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
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Recalls
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No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Ventana Medical Systems, Inc.Jul 16, 2015
K142965 · Virtuoso System for IHC PR (1E2) using iScan HT
- Omnyx, LLCApr 1, 2014
K131140 · OMNYX IDP FOR HER2 MANUAL APPLICATION
- Philips Medical Systems Nederland B.V.Sep 19, 2013
K130021 · PHILIPS HERCEPTEST DIGITAL SCORE
- Olympus America Inc. / Scientific Equipment GroupAug 21, 2012
K111914 · VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
- Aperio TechnologiesOct 31, 2008
K080254 · SCANSCOPE XT SYSTEM
- Aperio TechnologiesDec 28, 2007
K071671 · SCANSCOPE XT SYSTEM