Lucy Point-of-Care Magnetic Resonance Imaging Device

System, Nuclear Magnetic Resonance Imaging

Hyperfine Research, Inc.

The following data is part of a premarket notification filed by Hyperfine Research, Inc. with the FDA for Lucy Point-of-care Magnetic Resonance Imaging Device.

Pre-market Notification Details

Device IDK192002
510k NumberK192002
Device Name:Lucy Point-of-Care Magnetic Resonance Imaging Device
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Hyperfine Research, Inc. 530 Old Whitfield Street Guilford,  CT  06437
ContactBrian Sawin
CorrespondentBrian Sawin
Hyperfine Research, Inc. 530 Old Whitfield Street Guilford,  CT  06437
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-26
Decision Date2020-02-06

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.