Automated Digital Image Manual Interpretation Microscope
FDA product code OEO · Class II (moderate risk) · 21 CFR 864.1860 · Hematology
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.
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142965 | Virtuoso System for IHC PR (1E2) using iScan HTOEO · Traditional | Ventana Medical Systems, Inc. | 07/16/2015SE |
| K131140 | Omnyx Idp for HER2 Manual ApplicationOEO · Traditional | Omnyx, LLC | 04/01/2014SE |
| K130021 | Philips Herceptest Digital ScoreOEO · Traditional | Philips Medical Systems Nederland B.V. | 09/19/2013SE |
| K111914 | Virtual Slide System, Olympus VS800 SystemOEO · Traditional | Olympus America Inc. / Scientific Equipment Group | 08/21/2012SE |
| K080254 | Scanscope XT SystemOEO · Traditional | Aperio Technologies | 10/31/2008SE |
| K071671 | Scanscope XT SystemOEO · Traditional | Aperio Technologies | 12/28/2007SE |