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FDA 510(k) Applications Submitted by Hyperfine Research, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K192002
07/26/2019
Lucy Point-of-Care Magnetic Resonance Imaging Device
Hyperfine Research, Inc.
K201722
06/23/2020
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine Research, Inc.
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