Clearance Summary
TraumaCad Neo (1.1) received FDA 510(k) clearance under submission number K243810, sponsored by Brainlab , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-06-04.
- Submission: K243810
- Applicant / Sponsor: Brainlab , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2025-06-04
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.