Intended Use

The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces cross-sectional images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the head, body, or extremities. It assists in diagnosis and can be used during interventional procedures with MR compatible devices.

Technology

These MRI systems include new and modified hardware (such as patient tables, gradient systems, and new coils) and AI-enabled software features (like Deep Resolve Boost and Sharp for improved image reconstruction and workflow automation tools like myExam Assist and Autopilot). The technology focuses on enhanced image quality, automated anatomical alignment, and streamlined radiology workflows.

Performance

Performance was evaluated using nonclinical testing: sample clinical images, image quality assessments comparing new AI features against predicate devices, and bench tests for hardware and software changes. AI applications such as AutoAlign and Deep Resolve features were validated with separate training/validation/test datasets. The tests showed improved image sharpness and artifact reduction with accuracy up to 97.2% for AutoAlign and consistently strong image quality metrics (PSNR, SSIM) for Deep Resolve features.

Predicate Devices

No predicate devices specified

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