MAGNETOM Free.Max; MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.MAGNETOM Free.Max and MAGNETOM Free.Star are magnetic resonance diagnostic devices produced by Siemens that generate high-quality MRI images of the head, body, or extremities in multiple planes. These systems assist clinicians in diagnosis and can be used during interventional procedures with MR-compatible tools. They incorporate advanced AI-powered features to enhance image quality and scanning efficiency.
Intended Use
MAGNETOM Free.Max and MAGNETOM Free.Star are magnetic resonance diagnostic devices that produce cross-sectional images showing the internal structure and/or function of the head, body or extremities. Images and derived physical parameters, when interpreted by trained physicians, assist in diagnosis. Free.Max may also be used for imaging during interventional procedures with MR-compatible devices such as MR Safe biopsy needles.
Technology
The system includes new and modified hardware components such as a contour knee coil, respiratory sensor, myExam 3D camera, and upgraded host computer and MaRS hardware. Software features incorporate AI-powered Deep Resolve Boost for improved image reconstruction, injector coupling, respiratory sensor support, and interactive applications to enhance scanning procedures.
Performance
Performance was validated through software verification and validation, clinical image sampling, and adherence to FDA guidance documents. The Deep Resolve Boost AI feature was trained on over 26,000 2D slices from various body regions, demonstrating improved image quality metrics such as PSNR and SSIM. No new clinical tests were performed but sample clinical images were reviewed.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/2/2023
5 months - 2
FDA Approval
11/9/2023
Other devices from Siemens Medical Solutions USA, Inc.
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