Clearance Summary
Cercare Medical Neurosuite received FDA 510(k) clearance under submission number K230016, sponsored by Cercare Medical A/S. 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: K230016
- Applicant / Sponsor: Cercare Medical A/S
- 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 LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.