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Hyperfine, Inc.

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

Total Devices13
Categories2
Latest Approval2025-12-12
TypeNumberDevice NameCodeDate
510(k) K253489 Swoop® Portable MR Imaging® System LNH 2025-12-12 View
510(k) K250236 Swoop® Portable MR Imaging® System (V2) LNH 2025-05-30 View
510(k) K251276 Swoop® Portable MR Imaging® System LNH 2025-05-21 View
510(k) K240944 Swoop® Portable MR Imaging® System LNH 2024-07-16 View
510(k) K232760 Swoop® Portable MR Imaging System® LNH 2023-10-06 View
510(k) K230208 Swoop® Portable MR Imaging System™ LNH 2023-02-22 View
510(k) K223268 BrainInsight QIH 2022-12-16 View
510(k) K223247 Swoop Portable MR Imaging System LNH 2022-12-06 View
510(k) K221923 Swoop Portable MR Imaging System LNH 2022-07-28 View
510(k) K220815 BrainInsight QIH 2022-07-19 View
510(k) K221393 Swoop Portable MR Imaging System LNH 2022-06-10 View
510(k) K212456 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System LNH 2021-11-17 View
510(k) K211818 Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System LNH 2021-07-07 View
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