OEO
6 FDA 510(k) clearances · Product code
275 daysmedian time to decision
412 days90th percentile
6clearances measured
FDA profile
- Official device name
- Automated Digital Image Manual Interpretation Microscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.1860
- Medical specialty
- Hematology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| Virtuoso System for IHC PR (1E2) using iScan HT (K142965) | Ventana Medical Systems, Inc. | 2015-07-16 |
| OMNYX IDP FOR HER2 MANUAL APPLICATION (K131140) | Omnyx, LLC | 2014-04-01 |
| PHILIPS HERCEPTEST DIGITAL SCORE (K130021) | Philips Medical Systems Nederland B.V. | 2013-09-19 |
| VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM (K111914) | Olympus America Inc. / Scientific Equipment Group | 2012-08-21 |
| SCANSCOPE XT SYSTEM (K080254) | Aperio Technologies | 2008-10-31 |
| SCANSCOPE XT SYSTEM (K071671) | Aperio Technologies | 2007-12-28 |
Track OEO automatically
Every clearance here is in the API, with alerts when new ones post.