Hyperfine, Inc.
Hyperfine, Inc. appears in FDA public data with 0 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 19, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K262622 | Swoop® Portable MR Imaging® System | August 19, 2026 |
| K253489 | Swoop® Portable MR Imaging® System | December 12, 2025 |
| K250236 | Swoop® Portable MR Imaging® System (V2) | May 30, 2025 |
| K251276 | Swoop® Portable MR Imaging® System | May 21, 2025 |
| K240944 | Swoop® Portable MR Imaging® System | July 16, 2024 |
| K232760 | Swoop® Portable MR Imaging System® | October 6, 2023 |
| K230208 | Swoop® Portable MR Imaging System | February 22, 2023 |
| K223268 | BrainInsight | December 16, 2022 |
| K223247 | Swoop Portable MR Imaging System | December 6, 2022 |
| K221923 | Swoop Portable MR Imaging System | July 28, 2022 |
| K220815 | BrainInsight | July 19, 2022 |
| K221393 | Swoop Portable MR Imaging System | June 10, 2022 |
| K212456 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | November 17, 2021 |
| K211818 | Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System | July 7, 2021 |