Swoop� Portable MR Imaging System�
Hyperfine, Inc.The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable, ultra-low field MR imaging device designed to produce images of the internal structures of the head. It uses deep learning algorithms to improve image quality by reducing noise and blurring, helping clinicians at the point of care obtain diagnostic information even when full diagnostic exams are impractical.
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
Portable ultra-low field MRI producing images with standard MRI contrasts. Uses a commercial off-the-shelf tablet interface. Image reconstruction algorithm utilizes deep learning to improve image quality for T1W, T2W, and FLAIR sequences, reducing image noise and blurring. Includes software for pulse sequence parameters and DWI image post-processing.
Performance
Performance testing included software verification, image quality testing, software validation, biocompatibility, cleaning/disinfection validation, electrical safety, electromagnetic compatibility, specific absorption rate characterization, and cybersecurity testing. All tests passed according to internal requirements and applicable standards. Testing leveraged prior predicates where applicable to support equivalence without new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/8/2023
28 days - 2
FDA Approval
10/6/2023
Other devices from Hyperfine, Inc.
- Swoop� Portable MR Imaging� System2024 • 510K
- Swoop� Portable MR Imaging System�2023 • 510K
- BrainInsight2022 • 510K
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