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Hyperfine Research, Inc.

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

Total Devices3
Categories2
Latest Approval2021-01-07
TypeNumberDevice NameCodeDate
510(k) K202414 BrainInsight LLZ 2021-01-07 View
510(k) K201722 Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System LNH 2020-08-11 View
510(k) K192002 Lucy Point-of-Care Magnetic Resonance Imaging Device LNH 2020-02-06 View