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SIGNA MAGNUS system is a head-only magnetic resonance scanner designed to support high resolution, high signal-tonoise ratio, diffusion-weighted imaging, and short scan times. SIGNA MAGNUS is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the head, neck, TMJ, and limited cervical spine on patients 6 years of age and older. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by SIGNA MAGNUS reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

SIGNA MAGNUS is a 3.0T high-performance magnetic resonance imaging system designed to support imaging of the head, neck, TMJ and limited cervical spine. The system supports scanning in axial, coronal, sagittal, oblique, and double oblique planes using a variety of pulse sequences, imaging techniques, acceleration methods, and reconstruction algorithms. The system can be delivered as a new system installation, or as an upgrade to existing compatible whole-body 3.0T MR

Key aspects of the system design:
• An asymmetrically designed, head-only gradient coil that achieves up to 300 mT/m peak gradient amplitude and 750 T/m/s peak slew rate.
• A graduated patient bore size, starting at 74 cm at the entry down to 37 cm at isocenter.
• Uses the same magnet as a conventional whole-body 3.0T system, with integral active shielding and a zero boil-off cryostat.
• Can be installed as a new system or upgraded from an existing compatible whole-body 3.0T MR system.
• A dockable mobile patient table.
• Oscillating Diffusion Encoding (ODEN) - a spectral diffusion technique that uses a sinusoidal diffusion gradient waveform.

The provided text is a 510(k) Summary for the GE Healthcare SIGNA MAGNUS, a magnetic resonance diagnostic device. The summary indicates that this device did not require clinical studies to support substantial equivalence. Therefore, there are no acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or other details related to clinical performance studies to report for this device, as these were not performed or deemed necessary by the manufacturer for this submission.

The document states:
"The subject of this premarket submission, SIGNA MAGNUS did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of SIGNA MAGNUS in accordance with the FDA Guidance 'Submission of Premarket Notifications fo October 10, 2023. The image quality of SIGNA MAGNUS is substantially equivalent to that of the predicate device."

This means that the substantial equivalence was primarily based on non-clinical tests and a comparison of technological characteristics and indications for use with a predicate device (SIGNA Premier (K193282)). The non-clinical tests focused on safety and performance in compliance with various voluntary standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, IEC62464-1, ISO 10993-1, NEMA MS, NEMA PS3 DICOM).

Due to the absence of a clinical study, the requested information cannot be extracted from the provided text.

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