510(k) K192002
K192002 is an FDA 510(k) premarket notification submitted by Hyperfine Research, Inc. for the device "Lucy Point-of-Care Magnetic Resonance Imaging Device". The FDA issued a decision of Substantially Equivalent on Feb 6, 2020. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Hyperfine Research, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 6, 2020
- Date Received
- Jul 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)