The following data is part of a premarket notification filed by Hyperfine, Inc. with the FDA for Swoop Portable Mr Imaging System.
| Device ID | K221393 |
| 510k Number | K221393 |
| Device Name: | Swoop Portable MR Imaging System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Hyperfine, Inc. 351 New Whitfield Street Guilford, CT 06437 |
| Contact | Christine Kupchick |
| Correspondent | Christine Kupchick Hyperfine, Inc. 351 New 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 | 2022-05-13 |
| Decision Date | 2022-06-10 |