# Automated Digital Image Manual Interpretation Microscope
> **Product code: OEO** · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.1860
## Classification
- **FDA Product Code:** OEO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 864.1860
- **Review panel:** PA
- **Medical specialty:** Hematology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 6
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OEO)
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