Aiforia® Clinical AI Model for Breast Cancer; Ki67

Primary DI

06429810612014

Basic UDI-DI Code

B-06429810612014

Reference

Aiforia® Clinical AI Model for Breast Cancer; Ki67 v1.0

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Aiforia Technologies Plc

Aiforia® Clinical AI Model for Breast Cancer; Ki67 is intended for use with digital images of Ki67 stained normal and cancerous breast tissue of human specimens. The product supports the detection of tumor epithelium and scoring of Ki67 positive and negative cells of epithelial origin from the whole slide images or the selected image areas. The product enables viewing and selection of areas with high density of ki67-positive cells (“hotspots”) and displays results of the image analysis. A medical professional can view images for a patient case in different magnifications and move in different x-y-z-locations, view image analysis results, and mark and measure features in the images. The product supports the user’s visual interpretation and assists the medical professional in making the diagnosis. The product is an aid to diagnosis but is not the sole basis for diagnosis. The medical professional has the full responsibility for the clinical report.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).