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Devices

Hyperfine, Inc.

12 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.

DateSubmissionDevicePanelCode
December 12, 2025K253489Swoop® Portable MR Imaging® SystemRadiologyLNH
May 30, 2025K250236Swoop® Portable MR Imaging® System (V2)RadiologyLNH
May 21, 2025K251276Swoop® Portable MR Imaging® SystemRadiologyLNH
July 16, 2024K240944Swoop® Portable MR Imaging® SystemRadiologyLNH
October 6, 2023K232760Swoop® Portable MR Imaging System®RadiologyLNH
February 22, 2023K230208Swoop® Portable MR Imaging System™RadiologyLNH
December 16, 2022K223268BrainInsightRadiologyQIH
December 6, 2022K223247Swoop Portable MR Imaging SystemRadiologyLNH
July 28, 2022K221923Swoop Portable MR Imaging SystemRadiologyLNH
July 19, 2022K220815BrainInsightRadiologyQIH
June 10, 2022K221393Swoop Portable MR Imaging SystemRadiologyLNH
November 17, 2021K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemRadiologyLNH