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

SIGNA™ Hero is a whole body magnetic resonance scanner designed to support high resolution, high signal to-noise ratio, and short scan times. The systems use 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 oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 3.0T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The SIGNA Architect system is a whole body magnetic resonance scanner designed to support 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, TMJ, spine, breat, abdomen, pelvis, joints, prostate, blood vessels, and musculoskelatal regions of the region of interest being imaged, contrast agents may be used. The images produced by the SIGNA Architect system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

SIGNA Architect is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system features a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can imaqe in the saqittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. This submission is prompted by the introduction of two new software features called HyperSense 2.0 and Star onto SIGNA Architect. HyperSense 2.0 is an acceleration technique based on sparse data compressibility allowing scan time reduction while maintaining SNR efficiency. Star is a motion-robust, free-breathing imaging technique. HyperSense 2.0 is a modification to the previously cleared HyperSense, while Star is a technique that can be used with the previously cleared DISCO feature. Both HyperSense and DISCO are listed above as reference devices along with their associated 510(k) submission numbers. The addition of both the HyperSense 2.0 and Star features involved modifications to the SIGNA Architect system software. There were no changes from either of these features that were related to the system's hardware components.

The SIGNA Premier system is a whole body magnetic resonance scanner designed to support 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, TMJ, 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 the SIGNA Premier system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

SIGNA Premier is a whole-body magnetic resonance scanner featuring a 3.0T superconducting magnet with a 70cm bore size. Major elements of the system include the magnet, gradient coils, body RF transmit coil, RF receive subsystem, patient support system (table), host computer, and system software. The system is compatible with a suite of RF receive coils, and is capable of using various pulse sequences, imaging techniques and reconstruction algorithms. This submission is prompted by the introduction of a new software feature called AIR Recon DL onto the SIGNA Premier system. AIR Recon DL is a deep-learning based reconstruction technique designed to improve signal-to-noise ratio (SNR) and image sharpness. The feature also enables shorter scan times while preserving SNR and image sharpness. The addition of the AIR Recon DL feature involved modifications to the SIGNA Premier system software. There were no changes related to AIR Recon DL to the system's hardware components.

The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, coronal, and oblique images, spectroscopic images, parametric maps, and or spectra, dynamic images of the structures of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, 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 the Discovery MR750 3.0T, Discovery MR750w 3.0T and the Optima MR450w I.ST systems reflect the spaial 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.

The Discovery MR750 3.0T. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The Systems each feature a superconducting magnet. The data acquisition system accommodates up to 32 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The DV24 release is introducing new software features onto these existing MR Systems. There are also hardware modifications to the GEM configurations for Silenz compatibility. The Silenz feature used to reduce the acoustic noise generated during an MR examination is only available on the Optima MR450w GEM and Discovery MR750w GEM configurations. The Discovery MR750 3.0T. Discovery MR450 1.5T. Discovery MR750w 3.0T and the Optima MR450w 1.5T Systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The Optima™ MR450w 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, TMJ, 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 the Optima™ MR450w 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.

The 1.5 GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 32 independent receive channels in various increments, and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic 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 and reconstruction algorithms. The Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination. This application is compatible on the Optima MR450w system with GEM configuration. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).