The following data is part of a premarket notification filed by Hyperfine, Inc. with the FDA for Swoop Point-of-care Magnetic Resonance Imaging (poc Mri) Scanner System.
| Device ID | K211818 |
| 510k Number | K211818 |
| Device Name: | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hyperfine, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Contact | Christine Kupchick |
| Correspondent | Christine Kupchick Hyperfine, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-11 |
| Decision Date | 2021-07-07 |