Hyperfine Regulatory Clearances

February 2020. Swoop^_® system. The world’s first bedside Magnetic Resonance Imaging (MRI) system for brain imaging of patients aged two and up. (US FDA K192002)

August 2020. Swoop system. For brain imaging of all patient ages. (US FDA K201722)

July 2021. Swoop system. Additional automatic alignment and motion correction features. Automatic alignment provides images in standard anatomical orientation, regardless of the patient’s physical orientation. Motion correction detects and reacquires diffusion-weighted imaging (DWI) data if corrupted by motion. (US FDA K211818)

November 2021. Swoop system. Deep learning image reconstruction techniques that enhance the quality of T1, T2, and FLAIR images generated by a portable MRI system at a patient’s bedside. (US FDA K212456)

June 2022. Swoop system. Adds a new T1 (Standard) sequence optimized for imaging internal brain structures and a new Fast T2 sequence with a shorter scan time. (US FDA K221393)

December 2022. Swoop system. Improved DWI image quality due to increased signal-to-noise ratio. Expanded field of view for T1, T2, and FLAIR sequences. Retrained advanced reconstruction models. (US FDA K223247)

February 2023. Swoop system. Significantly improved DWI image quality and more robust compensation for subtle patient motion. Improved noise correction and uniformity correction for all sequences. (US FDA K230208)

October 2023. Swoop system. Adds advanced denoising for DWI image post-processing. Improved image quality for all sequences. (US FDA K232760)

July 2024. Swoop system. Significantly faster sequence scan times. New system quality control test features to support users with accreditation needs. (US FDA K240944)

May 2025. Swoop system. Introduces Optive AI™ software for use on current Swoop systems, which substantially improves image quality with advanced denoising and reduction of blur. (US FDA K251276)

June 2025. Swoop system. Introduces usability improvements, larger patient opening, and more uniform image consistency allowing Optive AI software to make images look even better. (US FDA K250236)