Clearance Summary
Galen Second Read received FDA 510(k) clearance under submission number K241232, sponsored by Ibex Medical Analytics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2025-01-24.
- Submission: K241232
- Applicant / Sponsor: Ibex Medical Analytics , Ltd.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3750
- Decision date: 2025-01-24
Classification & Regulation
This clearance is catalogued under FDA product code QPN and 21 CFR 864.3750, within the Pathology review panel as a Class II device.