Swoop Portable MR Imaging System
Hyperfine, Inc.The Swoop Portable MR Imaging System by Hyperfine, Inc. is a bedside portable MRI device designed to produce internal head images using magnetic resonance imaging. It allows clinicians to perform imaging at the point of care when full diagnostic exams are not practical. Its AI-enabled reconstruction algorithm enhances image quality by reducing noise and blurring for multiple MRI sequences, helping physicians with diagnosis.
Intended Use
Hyperfine Swoop Portable MR Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Technology
The system is a portable MRI that uses a 63.3 mT permanent magnet with a head coil, a commercial-off-the-shelf interface device for control, and deep learning-based image reconstruction algorithms for T1W, T2W, and FLAIR sequences to reduce noise and blurring.
Performance
Performance testing included image quality verification using NEMA and ACR phantom testing standards, electrical safety and EMC testing per ANSI/AAMI and IEC standards, biocompatibility, cleaning/disinfection validation, cybersecurity, software verification and validation consistent with FDA guidance. Testing confirmed the device met internal requirements and applicable standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/1/2022
27 days - 2
FDA Approval
7/28/2022
Other devices from Hyperfine, Inc.
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