Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.The Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) System by Hyperfine, Inc. is a portable MRI device designed to provide bedside imaging of the brain. It uses advanced deep learning for image reconstruction to reduce noise and blurring, enabling clinicians to view internal head structures more clearly. This system facilitates quicker and more accessible brain imaging in various care settings, aiding in diagnosis without the need to transport patients to traditional MRI suites.
Intended Use
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. Images interpreted by trained physicians to assist in diagnosis.
Technology
A portable MRI system with a commercial off-the-shelf user interface providing touchscreen menus and controls. Utilizes deep learning in the image reconstruction pipeline for T1W, T2W, and FLAIR sequences to improve image quality through advanced gridding and denoising steps.
Performance
Performance testing included verification of advanced reconstruction models to ensure no image quality degradation or introduction of artifacts, validation of functionality stability, security vulnerability testing, and biocompatibility testing of patient-contacting materials. Testing demonstrated that the new deep learning reconstruction does not raise new safety or effectiveness concerns compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/5/2021
3 months - 2
FDA Approval
11/17/2021
Other devices from Hyperfine, Inc.
- Swoop� Portable MR Imaging� System2024 • 510K
- Swoop� Portable MR Imaging System�2023 • 510K
- Swoop� Portable MR Imaging System�2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.