Swoop� Portable MR Imaging� System
Hyperfine, Inc.The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable ultra-low field MRI device designed to image the internal structure of the head. It provides physicians with useful diagnostic images in environments where full diagnostic examination is not practical. The system uses deep learning reconstruction algorithms to improve image quality and is intended for use at the point of care, such as emergency rooms and intensive care units, enhancing access to MRI imaging in diverse clinical settings.
Intended Use
The Swoop Portable MR Imaging System is a portable, ultra-low field 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 device is a portable, ultra-low field MRI with a 63.3 mT permanent magnet. It uses standard MRI contrasts and incorporates a commercial off-the-shelf tablet interface for operation. Image reconstruction algorithms utilize deep learning to improve quality of T1W, T2W, FLAIR, and DWI sequences. Additional features include noise correction, image distortion correction, and coil intensity correction.
Performance
Performance testing included software verification, image quality testing against multiple NEMA and ACR standards, cybersecurity testing, software validation, biocompatibility, cleaning/disinfection validation, electrical safety, and SAR characterization. All testing met internal requirements and applicable standards, demonstrating safety and efficacy. Some testing results were leveraged from a predicate device with identical conditions.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/5/2024
3 months - 2
FDA Approval
7/16/2024
Other devices from Hyperfine, Inc.
- Swoop� Portable MR Imaging System�2023 • 510K
- Swoop� Portable MR Imaging System�2023 • 510K
- BrainInsight2022 • 510K
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