Clearance Summary
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review received FDA 510(k) clearance under submission number K190664, sponsored by Brainlab AG. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-04-12.
- Submission: K190664
- Applicant / Sponsor: Brainlab AG
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2019-04-12
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.