Swoop� Portable MR Imaging System�
Hyperfine, Inc.The Swoop Portable MR Imaging System by Hyperfine is a bedside portable MRI device designed to produce images of the internal structure of the head. It uses magnetic resonance imaging with advanced image reconstruction algorithms that include deep learning to enhance image quality by reducing noise and blurring. This helps clinicians obtain diagnostic images even when full diagnostic examination is not practical, aiding diagnosis at the point of care in facilities such as emergency and critical care units.
Intended Use
The 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
Portable MRI device enabling patient bedside imaging, using a 63.3 mT permanent magnet and advanced reconstruction algorithms including deep learning for T1W, T2W, and FLAIR sequences with noise and uniformity corrections.
Performance
Verification and validation testing per IEC 62304 and FDA guidances showed the software meets requirements. Image quality met NEMA and ACR standards. Additional biocompatibility, cleaning, electrical safety, and cybersecurity testing passed as per relevant standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/25/2023
28 days - 2
FDA Approval
2/22/2023
Other devices from Hyperfine, Inc.
- Swoop� Portable MR Imaging� System2024 • 510K
- Swoop� Portable MR Imaging System�2023 • 510K
- BrainInsight2022 • 510K
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