OEO — Automated Digital Image Manual Interpretation Microscope Class II
Classification Details
- Product Code
- OEO
- Device Class
- Class II
- Regulation Number
- 864.1860
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142965 | ventana medical systems | Virtuoso System for IHC PR (1E2) using iScan HT | July 16, 2015 |
| K131140 | omnyx | OMNYX IDP FOR HER2 MANUAL APPLICATION | April 1, 2014 |
| K130021 | philips medical systems nederland | PHILIPS HERCEPTEST DIGITAL SCORE | September 19, 2013 |
| K111914 | olympus america inc. / scientific equipment group | VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM | August 21, 2012 |
| K080254 | aperio technologies | SCANSCOPE XT SYSTEM | October 31, 2008 |
| K071671 | aperio technologies | SCANSCOPE XT SYSTEM | December 28, 2007 |