Swoop® Portable MR Imaging® System

The Swoop Portable MR Imaging System is a portable, ultra-low field magnetic resonance imaging device designed to visualize internal head structures where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images provide information useful in determining diagnosis in adult and pediatric patients (≥0 years) in point-of-care settings such as emergency rooms, intensive care units, hospitals, and outpatient facilities.

The subject device maintains the same magnet type (permanent magnet at 63.3±2.0 mT or 64.9 mT nominal), patient bore dimensions, gradient system specifications, and RF coil design as the predicates. The primary modification is software enhancements to pulse sequences (T1W, T2W, FLAIR, DWI) utilizing deep learning-based image reconstruction algorithms to improve image quality, while maintaining identical operational parameters, patient weight capacity (1.6–200 kg), and anatomical focus (head imaging only).

Testing was performed per IEC 62304:2016 (software verification), NEMA MS 1-2008, MS 3-2008, MS 9-2008, MS 12-2016 (image performance), ISO 10993-1:2018 and ISO 10993-5:2009 (biocompatibility), ANSI/AAMI ES 60601-1:2005 and IEC 60601-1-2:2014 (electrical safety and EMC), FDA guidance on cybersecurity and software functions, and American College of Radiology standards for named sequences.

The subject device is substantially equivalent to predicates K250236 (Model 2) and K251276 (Model 1) because it shares identical intended use, patient population, anatomical site, energy modality, and hardware specifications. The software modifications to pulse sequences do not introduce new safety or efficacy concerns; testing demonstrates that advanced reconstruction preserves pathology contrast, improves image quality metrics, and maintains diagnostic consistency compared to linear reconstruction across multiple sequence types and pathologies.