Swoop® Portable MR Imaging® System (V2)

The Swoop Portable MR Imaging System (V2) is a portable, ultra-low field MRI device designed to produce images of the internal head structures where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide diagnostic information. It operates at point-of-care in professional healthcare facilities such as emergency rooms, intensive care units, hospitals, and rehabilitation centers.

The V2 has a larger patient-accessible bore (36.0 in. width vs 24.0 in.) and higher nominal field strength (64.9 mT vs 63.3 ± 2.0 mT) than the predicate V1. It features enhanced gradient amplitudes (up to 66.2 mT/m in Z-axis vs 38.5 mT/m), faster rise times, and includes new image processing capabilities such as Advanced Gridding reconstruction with FISTA and Advanced Denoising. The core operating principles, magnet type, RF coil design, and sequences (T1, T2, FLAIR, DWI/ADC) remain substantially similar.

Testing followed IEC 62304:2015 (software lifecycle), IEC 60601-1/1-2/1-6/2-33 (electrical safety and EMC), NEMA MS standards (MRI sequences), ISO 10993 biocompatibility standards, ISO 17664:2021 (reprocessing), FDA guidance on software functions and human factors, and ACR phantom test guidance.

The V2 shares identical intended use, patient population, anatomical site, and environment of use as the V1 predicate. Despite hardware improvements (larger bore, higher gradient strength) and software additions (Advanced Reconstruction using deep learning), these differences represent evolutionary refinements that do not raise new safety or efficacy questions. Performance testing confirmed Advanced Reconstruction preserves pathology contrast, maintains diagnostic consistency, and improves image quality compared to linear reconstruction across multiple sequence types and pathologies.