Aiforia® Clinical AI Model for Breast Cancer; ER
Basic Information
- Primary DI
- 06429810612038
- Basic UDI-DI Code
- B-06429810612038
- Reference
- Aiforia® Clinical AI Model for Breast Cancer; ER v1.0
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Aiforia Technologies Plc
Additional Description
The Aiforia® Clinical AI Model for Breast Cancer; ER is intended for use with digital images of ER-stained invasive breast cancer of human specimens. The product supports the detection of tumor epithelium and scoring of ER-positive and ER-negative cells of epithelial origin from whole slide images (WSI) or from selected image areas. The product enables viewing and selection of areas with high density of ER-positive cells (hotspots) and displays results of image analysis. A medical professional can view images for a patient case in different magnifications, view image analysis results, and mark and measure features in the images. The Aiforia® Clinical AI Model for Breast Cancer; ER supports user’s visual interpretation and assists the medical professional in making the diagnosis and should not be used as the sole basis for diagnosis. The product is intended to be used by qualified medical professionals.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0202050392 | LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - IVD MEDICAL DEVICE SOFTWARE |
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