# K241232: Galen™ Second Read™

- Pathway: 510(k) (Traditional)
- Applicant: Ibex Medical Analytics, Ltd.
- Decided: Jan 24, 2025 after 267 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
Longest line of descent: 1 generation back to DEN200080 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200080: Paige Prostate, Paige.Ai (2021) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241232
Methodology: https://510kreport.com/methodology