Cleared Traditional

K241232 - Galen™ Second Read™ (FDA 510(k) Clearance)

Class II Pathology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K241232 is an FDA 510(k) clearance for the Galen™ Second Read™. Classified as Software Algorithm Device To Assist Users In Digital Pathology (product code QPN), Class II - Special Controls.

Submitted by Ibex Medical Analytics , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on January 24, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3750 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ibex Medical Analytics , Ltd. devices

Submission Details

510(k) Number K241232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 77d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPN Software Algorithm Device To Assist Users In Digital Pathology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Pathology devices follow this clearance model.

Regulatory Peers - QPN Software Algorithm Device To Assist Users In Digital Pathology

Devices cleared under the same product code (QPN) and FDA review panel - the closest regulatory comparables to K241232.
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DEN200080 · Paige.Ai · Sep 2021