510(k) · Cleared
ClearedGalen™ Second Read™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibex Medical Analytics, Ltd. · QPN Software Algorithm Device To Assist Users In Digital Pathology
Cleared on Jan 24, 2025 as substantially equivalent to DEN200080 (Paige.Ai, 2021) after a 267-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Jan 24, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- QPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200080 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200080 Paige ProstatePaige.Ai · 2021
- This deviceK241232 Galen™ Second Read™Ibex Medical Analytics, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200080 | Paige Prostate | Paige.Ai | 2021 | — |
| 0 (this device) | K241232 | Galen™ Second Read™ | Ibex Medical Analytics, Ltd. | 2025 | — |
Sources: FDA 510(k) 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200080 | Paige ProstateSummary page 5…assist users in digital pathology Classification Panel: Pathology 510(k) Submission Number: K241232 Predicate device: Device Trade Name: Paige Prostate DeNovo Number: DEN200080 I Intended Use/Indications for Use: Galen™ Second Read™ is a software only device intended to analyze scanned histopathology… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2025, 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?
Galen™ Second Read™ is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Galen™ Second Read™ detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it…
Read the full statement (147 words)
Galen™ Second Read™ is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from prostate core needle biopsies (PCNB) prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. The device is intended to identify cases initially diagnosed as benign for further review by a pathologist. If Galen™ Second Read™ detects tissue morphology suspicious for prostate adenocarcinoma (AdC), it provides case- and slide-level alerts (flags) which includes a heatmap of tissue areas in the WSI that is likely to contain cancer.
Galen™ Second Read™ is intended to be used with slide images digitized with Philips Ultra Fast Scanner and visualized using the Galen™ Second Read™ user interface.
Galen™ Second Read™ outputs are not intended to be used on a standalone basis for diagnosis, to rule out prostatic AdC or to preclude pathological assessment of WSIs according to the standard of care.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241232: Galen™ Second Read™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241232
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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