Cleared Traditional

Galen? Second Read?

K241232 · Ibex Medical Analytics , Ltd. · Pathology
Jan 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K241232 is an FDA 510(k) clearance for the Galen? Second Read?, a Software Algorithm Device To Assist Users In Digital Pathology (Class II — Special Controls, product code QPN), submitted by Ibex Medical Analytics , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on January 24, 2025, 267 days after receiving the submission on May 2, 2024. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3750.

Submission Details

510(k) Number K241232 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2024
Decision Date January 24, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF

Device Classification

Product Code QPN — Software Algorithm Device To Assist Users In Digital Pathology
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.3750
Definition 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.