Clearance Summary
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) received FDA 510(k) clearance under submission number K223106, sponsored by Brainlab AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-07-14.
- Submission: K223106
- Applicant / Sponsor: Brainlab AG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2023-07-14
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.