MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
Siemens Medical Solutions USA, Inc.The MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit are MRI systems designed to produce detailed cross-sectional images and spectroscopic data of the head, body, and extremities. They support advanced imaging workflows and reconstruction frameworks, helping clinicians diagnose medical conditions by providing clear internal images and physical parameters. The system can also assist in interventional procedures with MR-compatible devices.
Intended Use
The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device that produces transverse, sagittal, coronal, and oblique cross-sectional images, spectroscopic images and/or spectra, displaying the internal structure and/or function of the head, body, or extremities.
Technology
The device includes new and modified hardware and software features including a 3D camera for patient positioning, simplified scan workflows for less experienced users, and an Open Recon Framework interface to apply FDA-cleared third-party reconstruction algorithms. It supports cardiac triggering using pilot tone technology and enhanced angiography planning tools.
Performance
The device underwent software verification and validation, electrical/mechanical safety testing, and electromagnetic compatibility testing. All tests passed, confirming the device meets relevant IEC standards and performs as intended with an equivalent safety and performance profile to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/15/2022
3 months - 2
FDA Approval
9/13/2022
Other devices from Siemens Medical Solutions USA, Inc.
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