Devices · Ibex Medical Analytics Ltd.

Galen™ Second Read™

Ibex Medical Analytics Ltd. is listed for Galen™ Second Read™ (K241232). The FDA list gives January 24, 2025 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QPN as “Software Algorithm Device To Assist Users In Digital Pathology”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241232

Official FDA database record

Date of final decision

January 24, 2025

Company on the FDA list

Ibex Medical Analytics Ltd.

Lead panel

Pathology

Primary product code

QPN

openFDA device name for the code

Software Algorithm Device To Assist Users In Digital Pathology

Device class

2

Regulation number

864.3750

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary