Swoop Portable MR Imaging System
Hyperfine, Inc.The Swoop Portable MR Imaging System is a bedside portable MRI device designed for producing images of the internal structure of the head when full diagnostic exams are not feasible. It uses advanced AI-based image reconstruction algorithms to enhance image quality with reduced noise and blurring, aiding clinicians in diagnosis at the point of care, such as emergency rooms or 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
The system is a portable MRI device using a 63.3 mT permanent magnet with image reconstruction algorithms that utilize deep learning to reduce noise and blurring in T1W, T2W, and FLAIR sequences. It includes a commercial off-the-shelf tablet interface for control and cloud storage interaction. Modifications include enhanced pulse sequences and noise correction features.
Performance
Verification and validation testing confirmed software functionality, image quality, cybersecurity, biocompatibility, cleaning, electrical safety, and performance characterization met applicable standards, supporting substantial equivalence to predicate device K212456 without new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/13/2022
28 days - 2
FDA Approval
6/10/2022
Other devices from Hyperfine, Inc.
- Swoop� Portable MR Imaging� System2024 • 510K
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- Swoop� Portable MR Imaging System�2023 • 510K
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