Hyperfine, Inc.
13 FDA 510(k) clearances · Manufacturer
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Swoop® Portable MR Imaging® System (K253489) | Hyperfine, Inc. | 2025-12-12 |
| Swoop® Portable MR Imaging® System (V2) (K250236) | Hyperfine, Inc. | 2025-05-30 |
| Swoop® Portable MR Imaging® System (K251276) | Hyperfine, Inc. | 2025-05-21 |
| Swoop® Portable MR Imaging® System (K240944) | Hyperfine, Inc. | 2024-07-16 |
| Swoop® Portable MR Imaging System® (K232760) | Hyperfine, Inc. | 2023-10-06 |
| Swoop® Portable MR Imaging System™ (K230208) | Hyperfine, Inc. | 2023-02-22 |
| BrainInsight (K223268) | Hyperfine, Inc. | 2022-12-16 |
| Swoop Portable MR Imaging System (K223247) | Hyperfine, Inc. | 2022-12-06 |
| Swoop Portable MR Imaging System (K221923) | Hyperfine, Inc. | 2022-07-28 |
| BrainInsight (K220815) | Hyperfine, Inc. | 2022-07-19 |
| Swoop Portable MR Imaging System (K221393) | Hyperfine, Inc. | 2022-06-10 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K212456) | Hyperfine, Inc. | 2021-11-17 |
| Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K211818) | Hyperfine, Inc. | 2021-07-07 |
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