OEO
- Product code
- OEO
- Device name
- Automated Digital Image Manual Interpretation Microscope
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.1860
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 6 (all years; only the last 3 years are listed here)
FDA classification 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.
Official FDA classification page: OEO
Classification and pathway per current FDA publications. Data from openFDA (CC0).