Paige Prostate Detect

CE & FDA | Prostate | Amplifier Integrator | H&E

Description of use

Paige Prostate Detect is offered and sold as part of the Paige Prostate Suite.

FDA Intended Use (USA): Assists in the detection of foci suspicious for cancer. After initial review by a pathologist, if suspicious tissue is detected, Paige indicates the location with the highest likelihood of having cancer. For use with images digitized with Philips Ultra Fast Scanner & visualized with Paige FullFocus. Paige Prostate Detect is an adjunctive and should not be used as the primary diagnosis.

CE-IVD Intended Use (EU): Assists in the detection of foci suspicious for cancer. If suspicious tissue is detected, it provides the location with the highest likelihood for cancer & a heatmap with areas for further review by a pathologist. For use with images digitized with Philips Ultra Fast & Leica AT2 scanners & visualized with Paige FullFocus.

The application content is provided by the respective AI vendors.