Pathology · 510(k) · 2025
Galen Second Read
Ibex Medical Analytics Ltd.. Cleared by FDA on 24 January 2025 under submission K241232, product code QPN (software algorithm device to assist users in digital pathology). What FDA's record says, in FDA's words.
Device record · K241232
- Device. Galen Second ReadDEVICE
- Company. Ibex Medical Analytics Ltd. (IL)COMPANY
- Decision. 24 January 2025, 510(k), substantially equivalent (traditional review); received 2 May 2024DECISION
- Panel. PathologyPANEL
- Product code. QPN, Software Algorithm Device To Assist Users In Digital PathologyCODE
- Regulation. 21 CFR 864.3750, Class IIREG
- Source. FDA database entry · decision document (15 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
The product code's definition, from FDA's classification record. A software algorithm device to assist users in digital pathology is an in vitro diagnostic device intended to evaluate acquired scanned pathology whole slide images. The device uses software algorithms to provide information to the user about presence, location, and characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in determining a pathology diagnosis.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedpathology slides
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QPN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QPN, in Pathology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.