MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Siemens Shenzhen Magnetic Resonance Ltd.MAGNETOM Flow.Ace and MAGNETOM Flow.Plus are advanced 1.5T MRI systems by Siemens that produce high-resolution images of the head, body, or extremities, using MR technology and optional local coils. Equipped with AI-powered software features such as Deep Resolve for image enhancement and AutoMate Cardiac for cardiac imaging automation, these devices help clinicians obtain detailed diagnostic images efficiently and safely, facilitating diagnosis and interventional procedures.
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
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