FDA.reportPublic FDA data

Hyperfine, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30143106983014310698Hyperfine, Inc1N2026-01-01351 New Whitfield Street Guilford CT US 06437

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860000606134Swoop Site Quality Assurance Phantom - The Site Quality Assurance Phantom is specifically designed as a medical device and augments the scanner by allowing weekly quality control checks of the functioning of the scanner in the hospital environment.775-476-2674support@hyperfine.io
00860000606141Swoop Point-of-Care Magnetic Resonance Imaging Scanner - The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.775-476-2674support@hyperfine.io

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2766961962652661K253489Swoop® Portable MR Imaging® SystemLNH2025-12-12
2766961062538510K223268BrainInsightQIH2022-12-16
2766961726755237
2766961816909335

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LNH12025-12-12
QIH12022-12-16

PMN#

GUDID#

Swoop Point-of-Care Magnetic Resonance Imaging Scanner - The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.

Hyperfine Operations, Inc.

2020-09-16