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Hyperfine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253489Swoop® Portable MR Imaging® SystemDecember 12, 2025
K250236Swoop® Portable MR Imaging® System (V2)May 30, 2025
K251276Swoop® Portable MR Imaging® SystemMay 21, 2025
K240944Swoop® Portable MR Imaging® SystemJuly 16, 2024
K232760Swoop® Portable MR Imaging System®October 6, 2023
K230208Swoop® Portable MR Imaging System™February 22, 2023
K223268BrainInsightDecember 16, 2022
K223247Swoop Portable MR Imaging SystemDecember 6, 2022
K221923Swoop Portable MR Imaging SystemJuly 28, 2022
K220815BrainInsightJuly 19, 2022
K221393Swoop Portable MR Imaging SystemJune 10, 2022
K212456Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemNovember 17, 2021
K211818Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemJuly 7, 2021