Source document or public record
FDA 510(k) K241232 — Galen Second Read
FDA 510(k) index record K241232. Device: Galen Second Read. Applicant as listed: Ibex Medical Analytics , Ltd.. Decision date: 2025-01-24.
Source
"device_name": "Galen Second Read"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K241232.
Device name: Galen Second Read. Applicant as listed: Ibex Medical Analytics , Ltd..
Decision date: 2025-01-24. Decision wording: Substantially Equivalent.
Product code: QPN. Regulation: 21 CFR 864.3750. Medical specialty: Pathology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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