Clearance Summary
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert received FDA 510(k) clearance under submission number K241989, 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 2024-12-06.
- Submission: K241989
- Applicant / Sponsor: Cercare Medical A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2024-12-06
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.