Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

System, Nuclear Magnetic Resonance Imaging

Hyperfine, Inc.

The following data is part of a premarket notification filed by Hyperfine, Inc. with the FDA for Swoop Point-of-care Magnetic Resonance Imaging (poc Mri) Scanner System.

Pre-market Notification Details

Device IDK212456
510k NumberK212456
Device Name:Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Hyperfine, Inc. 530 Old Whitfield Street Guilford,  CT  06437
ContactChristine Kupchick
CorrespondentChristine Kupchick
Hyperfine, Inc. 530 Old Whitfield Street Guilford,  CT  06437
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-05
Decision Date2021-11-17

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.