De Novo · Granted
GrantedPaige Prostate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paige.Ai · QPN Software Algorithm Device To Assist Users In Digital Pathology
Granted on Sep 21, 2021 as a new device type through De Novo after a 264-day review. 1 later device descends from it.
- Decided
- Sep 21, 2021
- Review
- 264 days
- Class
- Class II
- Product code
- QPN
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN200080 Paige ProstatePaige.Ai · 2021
- Descendant · cites it directly · 0 of its ownK241232 Galen™ Second Read™Ibex Medical Analytics, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241232Galen™ Second Read™Ibex Medical Analytics, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200080 | Paige Prostate | Paige.Ai | 2021 | — |
| +1 | K241232 | Galen™ Second Read™ | Ibex Medical Analytics, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QPN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QPN device
- #1 K241232 Galen™ Second Read™score 8.7 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241232 | Galen™ Second Read™ | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K241232 (Ibex Medical Analytics, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QPN devicesQPN Software Algorithm Device To Assist Users In Digital Pathology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QPN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPN
Too few QPN 510(k)s in any year since 2007 to give a median.
Recalls per year · QPN
No recall names QPN since 2007.
Adverse event reports per year · QPN
No MAUDE report names QPN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (150 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200080 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200080: Paige Prostate.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200080
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026