Swoop Portable MR Imaging 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 Portable Mr Imaging System.

Pre-market Notification Details

Device IDK221393
510k NumberK221393
Device Name:Swoop Portable MR Imaging System
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Applicant Hyperfine, Inc. 351 New Whitfield Street Guilford,  CT  06437
ContactChristine Kupchick
CorrespondentChristine Kupchick
Hyperfine, Inc. 351 New Whitfield Street Guilford,  CT  06437
Product CodeLNH  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-13
Decision Date2022-06-10

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