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Hyperfine, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories2
Latest FDA decision2025-12-12

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-06). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K253489 Swoop® Portable MR Imaging® SystemLNH2025-12-12 View
510(k) K250236 Swoop® Portable MR Imaging® System (V2)LNH2025-05-30 View
510(k) K251276 Swoop® Portable MR Imaging® SystemLNH2025-05-21 View
510(k) K240944 Swoop® Portable MR Imaging® SystemLNH2024-07-16 View
510(k) K232760 Swoop® Portable MR Imaging System®LNH2023-10-06 View
510(k) K230208 Swoop® Portable MR Imaging System™LNH2023-02-22 View
510(k) K223268 BrainInsightQIH2022-12-16 View
510(k) K223247 Swoop Portable MR Imaging SystemLNH2022-12-06 View
510(k) K221923 Swoop Portable MR Imaging SystemLNH2022-07-28 View
510(k) K220815 BrainInsightQIH2022-07-19 View
510(k) K221393 Swoop Portable MR Imaging SystemLNH2022-06-10 View
510(k) K212456 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH2021-11-17 View
510(k) K211818 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH2021-07-07 View

Related Clinical Trials

NCT07296263Evaluation of Gadolinium Based Contrast Agents for Portable MR Imaging SystemsENROLLING_BY_INVITATIONNCT04436068Hyperfine Portable MRI in Hydrocephalus and Other Conditions Prompting Outpatient Brain ImagingCOMPLETEDNCT06469801ECMO ABI Detection With HyperfineRECRUITINGNCT07702968Low-Field MRI in Stroke Code PatientsRECRUITING
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