The following data is part of a premarket notification filed by Hyperfine Research, Inc. with the FDA for Lucy Point-of-care Magnetic Resonance Imaging Device.
| Device ID | K192002 |
| 510k Number | K192002 |
| Device Name: | Lucy Point-of-Care Magnetic Resonance Imaging Device |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hyperfine Research, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Contact | Brian Sawin |
| Correspondent | Brian Sawin Hyperfine Research, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-26 |
| Decision Date | 2020-02-06 |