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The system is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The proposed device Revolution Ascend Sliding is a head and whole-body CT system composed of a gantry, transporter, operator console with a host computer, power distribution unit, and interconnection cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories/interconnections. Revolution Ascend Sliding generates cross-sectional images of the body by computer reconstruction of xray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes.

The OEC Elite MiniView (mobile mini C-Arm) is designed to provide physicians with real time goopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.

The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment, and surgical procedures of the shoulders, limbs, and extremities. The system consists of a C-arm attached to an image processing workstation. A CsI(TI) - CMOS flat panel detector and the identical X-ray source monoblock are used for image acquisition. The C-arm supports the high-voltage generator, X-ray tube, X-ray controls, collimator, and the FPD. The C-arm is capable of performing linear (vertical, horizontal, orbital) and rotational motions that allow the user to position the X-Ray imaging components at various angles and distances with respect to the patient extremity anatomy to be imaged. The C and support arm are mechanically balanced allowing for ease of movement and capable of being "locked" in place using an electronically controlled braking system. The workstation is a stable mobile platform that supports the C-arm, image display monitor(s), image processing equipment/software, recording devices, data input/output devices and power control systems.

The GE Optima CT520 Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The GE Optima CT520 CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The Optima CT520 CT Scanner System is composed of a gantry, patient table, operator console, and line voltage adaptor. It also includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.8 seconds per rotation. and can acquire up to 16 slices/rows of data per rotation with a maximum total collimation coverage of 20mm in the z direction. The system can be operated in Axial, Cine, Helical, Cardiac and Gated acquisition modes. To improve the siting footprint, the power distribution unit (PDU) has been integrated into the gantry base; except for standalone line voltage adaptor, if needed. The PDU components' function and performance remain the same. This change has been fully tested and certified by a NRTL to continue to meet all applicable IEC/UL safety standards. The Optima CT520 represents evolutionary modifications to the predicate device (BrightSpeed Elite Select CT System (K082816)). The modifications include hardware upgrades due to technology obsolesces (e.g. console), ROHS compliance, system siting footprint optimization, and IEC Edition 3 compliance, as well as software changes to improve workflow and usability. incorporate Dose Check and quality fixes, assist in product marketing position by feature availability, and feature technology flow-down from cleared premium tier products (e.g. ASiR), The Optima CT520 is a general purpose, mid-tier 16-slice CT scanner that incorporates GE's innovative technology and feature functionality. The Optima CT520 uses virtually the same materials and identical operating principle as our existing marketed product, except in the case of using the compensatory ROHS compliance material. The image chain components (tube, collimator, detector. DAS) are virtually identical to the BrightSpeed Elite Select. The changes do not affect the intended use, the indications for use, patient population nor fundamental operating principles of the currently commercially available predicate system and are the identical or similar to other GE CT systems and features previously cleared.

1.5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners 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 1.5T Brivo MR355 and 1.5T Optima MR360 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.

1.5T Brivo MR355 and 1.5T Optima MR360 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T Brivo MR355 and 1.5T Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.

The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.

The GE 8CH Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Protor nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques. The GE 8CH Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table. The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen. The GE 8CH Foot Ankle Coil is 8-element phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission. This coil is designed based on the same technology as the predicate device.

The Brivo MR355 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 Brivo MR355 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 modified Brivo MR355 adds (1) one dedicated coil: 4-ch Breast Array Coil: (2) two clinical applications: VIBRANT and 3D FIESTA-C. The coil and clinical applications are standard for predicate Optima MR360 (K103330). All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T Brivo MR355 features a superconducting magnet at 1:5 Tesla. The data acquisition system operating accommodates up to 8 independent receive channels in various increments, and multiple independent coil elements per channel The system uses a during a single acquisition series. 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 1.5T Brivo MR355 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

The Brivo MR355/ Optima MR360 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 Brivo MR355/ Optima MR360 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 Brivo MR355 / Optima MR360 is a new MR system that is similar in design to previous GE Healthcare 1.5T MR systems. All utilize superconducting magnets, gradients, and radio frequency coils and electronics to acquire data in single voxel, two dimensional, or three dimensional datasets. The 1.5T Brivo MR355 / Optima MR360 features a superconducting magnet operating at 1.5 Tesla. The data acquisition system accommodates up to 8 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 1.5T Brivo MR355 / Optima MR360 is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).