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Hyperfine Research, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest FDA decision2021-01-07
TypeNumberDevice NameCodeDateActions
510(k) K202414 BrainInsightLLZ2021-01-07 View
510(k) K201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner SystemLNH2020-08-11 View
510(k) K192002 Lucy Point-of-Care Magnetic Resonance Imaging DeviceLNH2020-02-06 View
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