Intended Use

Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.

Technology

Sonic DL is a deep learning based reconstruction algorithm integrated into GE Healthcare MR systems. It improves the speed of cardiac cine MR imaging by enabling acceleration factors as high as 12 and allows single heartbeat imaging with breath holds or free breathing, surpassing conventional parallel imaging acceleration techniques.

Performance

Nonclinical testing using simulated MR phantoms demonstrated that Sonic DL reconstructs images comparable in quality and temporal sharpness to fully sampled cine images. Clinical testing involving radiologists showed that functional cardiac measurements from Sonic DL images had less variability compared to conventional methods and that the images were of diagnostic quality with significantly reduced scan times. Additionally, Sonic DL supports free-breathing single heartbeat imaging showing good agreement with conventional measurements.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/23/2022

    6 months
  • 2

    FDA Approval

    5/30/2023

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.