Hyperfine, Inc.
Hyperfine, Inc. holds FDA 510(k) medical device clearances, first cleared 2021, most recent 2026.
Top product codes for Hyperfine, Inc.
Recent clearances by Hyperfine, Inc.
- K262622 — Swoop® Portable MR Imaging® System
- K253489 — Swoop® Portable MR Imaging® System
- K250236 — Swoop® Portable MR Imaging® System (V2)
- K251276 — Swoop® Portable MR Imaging® System
- K240944 — Swoop® Portable MR Imaging® System
- K232760 — Swoop® Portable MR Imaging System®
- K230208 — Swoop® Portable MR Imaging System
- K223268 — BrainInsight
- K223247 — Swoop Portable MR Imaging System
- K221923 — Swoop Portable MR Imaging System
- K220815 — BrainInsight
- K221393 — Swoop Portable MR Imaging System
- K212456 — Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
- K211818 — Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Data sourced from openFDA. This site is unofficial and independent of the FDA.