Search Results

The SIGNA™ Champion is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA™ Champion 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™ Champion is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/human reader performance study. The document is a 510(k) premarket notification for a Magnetic Resonance Diagnostic Device (SIGNA™ Champion).

The relevant sections state:

• "The subject of this premarket submission, the SIGNA™ Champion, 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 the SIGNA™ Champion in accordance with the FDA Guidance 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' issued on October 10, 2023. The image quality of the SIGNA™ Champion is substantially equivalent to that of the predicate device."

This indicates that the FDA clearance for the SIGNA™ Champion MR system was based on demonstrating substantial equivalence to a previous predicate device (SIGNA™ Voyager) through non-clinical testing and the review of sample clinical images, rather than a prospective clinical study involving human readers and AI assistance for diagnostic tasks.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-assisted diagnostic device performance study because such a study was not conducted or reported in this 510(k) submission.

Ask a specific question about this device