Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.
Hyperfine, Inc
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014310698 | 3014310698 | Hyperfine, Inc | 1 | N | 2026-01-01 | 351 New Whitfield Street Guilford CT US 06437 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 276696 | 1962652661 | K253489 | Swoop® Portable MR Imaging® System | LNH | 2025-12-12 |
| 276696 | 1062538510 | K223268 | BrainInsight | QIH | 2022-12-16 |
| 276696 | 1726755237 | ||||
| 276696 | 1816909335 |
Product Codes Associated With Registrations
PMN
Swoop® Portable MR Imaging® System
Hyperfine, Inc.
Swoop® Portable MR Imaging System®
Hyperfine, Inc.
Swoop® Portable MR Imaging System?
Hyperfine, Inc.
BrainInsight
Hyperfine, Inc.
Swoop Portable MR Imaging System
Hyperfine, Inc.
Swoop Portable MR Imaging System
Hyperfine, Inc.
BrainInsight
Hyperfine, Inc.
Swoop Portable MR Imaging System
Hyperfine, Inc.
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.
BrainInsight
Hyperfine Research, Inc
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine Research, Inc.
Lucy Point-of-Care Magnetic Resonance Imaging Device
Hyperfine Research, Inc.
GUDID
Swoop Transmit and Receive Radio Frequency Head Coil - The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.
2025-12-04
Swoop Portable MR Imaging Scanner - Portable MR Scanner (v2.2)
2025-12-04
Hyperfine Foam Head Pad - Memory foam cushion used as a support device to aid in the positioning of the patient’s head during an MRI procedure.
2023-01-25
Head Stabilizer - 900-11022-00
2024-12-11
Swoop Transmit and Receive Radio Frequency Head Coil - Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.9)
2023-02-16
Swoop Portable MRI Scanner - Swoop Portable MRI Scanner (Mk1.9)
2023-02-15
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner - Swoop POC MRI Scanner (Mk1.8 version)
2021-07-26
Swoop Transmit and Receive Radio Frequency Head Coil - Transmit and Receive Radio Frequency (RF) Head Coil for Use with the Swoop POC MRI Scanner (Mk1.8 version)
2021-07-26
BrainInsight - Version 1.0
2021-03-05
Swoop Transmit and Receive Radio Frequency Head Coil - The Transmit and Receive Radio Frequency Head Coil, like RF coils used on conventional high-field systems (e.g. 1.5T, 3T), is used to transmit RF pulses and to receive MR signals. It consists of one linear mode transmit coil, and an 8-channel receive phased array.
2020-09-16
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.
2020-09-16
Swoop 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.
2020-09-16