Logo
RadAI Slice
Subscribe

Intended Use

Vantage Fortian 1.5T systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA.

Technology

The device is a 1.5 Tesla MRI system using a lightweight magnet and advanced gradient coil and RF system components. It employs Canon Pianissimo™ Σ scan noise reduction technology, a new gradient coil from a different vendor, and AI-based image reconstruction (AiCE) to reduce artifacts and improve image quality. Several machine learning-based detection technologies assist in automatic scan plane positioning for liver, prostate, and spine.

Performance

Performance testing included image quality and artifact reduction evaluations using phantom and volunteer images. AI-based features like SureVOI Liver, LiverLine+, ProstateLine+, W-SpineLine+, Exsper, mART EXP, IMC, RDC DWI, and pCASL were tested and confirmed effective. Bench testing and risk management activities demonstrated compliance with safety and performance requirements.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/4/2021

    1 month
  • 2

    FDA Approval

    12/1/2021

Other devices from Canon Medical Systems Corporation

View all 31 devices

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.