Clearance Summary
Lucy Point-of-Care Magnetic Resonance Imaging Device received FDA 510(k) clearance under submission number K192002, sponsored by Hyperfine Research, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-02-06.
- Submission: K192002
- Applicant / Sponsor: Hyperfine Research, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2020-02-06
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.