Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups
Basic Information
- Primary DI
- 06429810612052
- Basic UDI-DI Code
- B-06429810612052
- Reference
- Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups v1.0
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Aiforia Technologies Plc
Additional Description
Aiforia® Clinical AI Model for Prostate Cancer; Gleason Grade Groups is intended for use with digital images of hematoxylin-eosin stained normal and cancerous human prostate tissue specimens. The product supports cancer detection and Gleason grade grouping from the whole slide images. A medical professional can view images for a patient case in different magnifications, view image analysis results, and mark and measure significant features in the images. Aiforia® Clinical AI for Prostate Cancer; Gleason Grade Groups 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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