Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Hyperfine Research, Inc.

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

Total Devices3
Categories0
Latest FDA decision
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
↑