# DEN200080: Paige Prostate

- Pathway: De Novo (Direct)
- Applicant: Paige.Ai
- Decided: Sep 21, 2021 after 264 days
- Product code: QPN (Software Algorithm Device To Assist Users In Digital Pathology)
- Device class: 2
- Regulation: 21 CFR 864.3750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K241232: Galen™ Second Read™ (2025), 0 descendants of its own

## Indications for use
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist. Paige Prostate is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized with Paige FullFocus WSI viewing software. Paige Prostate is an adjunctive computer-assisted methodology and its output should not be used as the primary diagnosis. Pathologists should only use Paige Prostate in conjunction with their complete standard of care evaluation of the slide image.

Source page: https://510kreport.com/device/DEN200080
Methodology: https://510kreport.com/methodology