Hyperfine, Inc.
Medical device manufacturer in Guilforf, CT.
14510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262622 | Swoop® Portable MR Imaging® SystemLNH · Special | 08/19/2026SE |
| K253489 | Swoop® Portable MR Imaging® SystemLNH · Special | 12/12/2025SE |
| K250236 | Swoop® Portable MR Imaging® System (V2)LNH · Traditional | 05/30/2025SE |
| K251276 | Swoop® Portable MR Imaging® SystemLNH · Special | 05/21/2025SE |
| K240944 | Swoop® Portable MR Imaging® SystemLNH · Special | 07/16/2024SE |
| K232760 | Swoop® Portable MR Imaging System®LNH · Special | 10/06/2023SE |
| K230208 | Swoop® Portable MR Imaging SystemLNH · Special | 02/22/2023SE |
| K223268 | BrainInsightQIH · Traditional | 12/16/2022SE |
| K223247 | Swoop Portable MR Imaging SystemLNH · Special | 12/06/2022SE |
| K221923 | Swoop Portable MR Imaging SystemLNH · Special | 07/28/2022SE |
| K220815 | BrainInsightQIH · Traditional | 07/19/2022SE |
| K221393 | Swoop Portable MR Imaging SystemLNH · Special | 06/10/2022SE |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH · Traditional | 11/17/2021SE |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH · Special | 07/07/2021SE |