MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc.The MAGNETOM Free.Max and MAGNETOM Free.Star are advanced magnetic resonance imaging (MRI) systems designed by Siemens. These devices produce detailed cross-sectional images of the body to help clinicians visualize internal structures and diagnose various conditions. Featuring new software and hardware enhancements, they provide improved imaging workflows, patient comfort with different bore sizes, and automated shoulder examination support, aiding physicians in accurate diagnosis and patient management.
Intended Use
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images may also be produced. Depending on the region of interest, contrast agents may be used. These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist in diagnosis.
Technology
The devices include hardware and software upgrades such as options for dual scanner user interfaces, 3D camera for auto registration of patient height/weight/orientation, new patient video, new local coils, and a high-load patient table for heavy patients. Software enhancements include myExam Shoulder Autopilot for automated shoulder exams, new pulse sequences optimized for brain perfusion imaging, and real-time inline perfusion calculation. The devices conform to IEC 62304 medical device software standards and use established MRI components, maintaining safety and performance equivalence to predicate devices.
Performance
The performance testing included clinical image samples, bench tests for coil signal-to-noise ratio and heating measurements, and software verification and validation of new and modified software features. The results demonstrated that the devices perform as intended and are substantially equivalent in safety and performance to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/28/2022
3 months - 2
FDA Approval
6/24/2022
Other devices from Siemens Medical Solutions USA, Inc.
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