MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc.The MAGNETOM Free.Max is a magnetic resonance imaging (MRI) system that creates detailed cross-sectional images of the internal structures and functions of the head, body, and extremities. It includes advanced hardware and software features to enhance image quality and assist clinicians in diagnosing various conditions by providing clear and accurate images.
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
MAGNETOM Free.Max is an 80 cm bore 0.55T superconducting magnet MRI system with advanced hardware such as new gradient coils, RF system, patient table, coils (body, head/neck, spine, BioMatrix coils), and software features like Sequence Booster, SMS Averaging, SWI with 3D segmented EPI, Deep Resolve Gain/Sharp, and a new user interface including myExam Companion.
Performance
Performance testing included sample clinical images for image quality and pulse sequences, performance bench tests for SNR and coil heating, software verification and validation per medical device software standards, and a small clinical study assessing peripheral nerve stimulation effects. The testing demonstrated safety and equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/1/2021
4 months - 2
FDA Approval
7/1/2021
Other devices from Siemens Medical Solutions USA, Inc.
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