Intended Use

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device that produces cross-sectional and spectroscopic images and/or spectra of the head, body, or extremities, enabling diagnosis by trained physicians.

Technology

MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are 1.5T MRI systems with new hardware including magnet, gradient coil, RF system, local coils, patient tables, and computer systems, combined with syngo MR XA70A software featuring AI-based imaging enhancements such as Deep Resolve and AutoMate Cardiac, BioMatrix patient adaptation, DryCool technology for efficient cooling, and Eco Power Mode to reduce energy consumption.

Performance

Performance testing included assessments of image quality from new and modified pulse sequences, coil heating and SNR measurements, and software verification and validation, demonstrating equivalent safety and effectiveness to the predicate device. AI features were trained on extensive datasets covering multiple body parts and validated via quantitative metrics (PSNR, SSIM, NMSE) and visual evaluation.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    2/14/2025

    4 months
  • 2

    FDA Approval

    6/16/2025

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.