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Indications For Use of GE LightSpeed™ ACT FP16 when configured as a CT System: The GE LightSpeed™ ACT FP16 is indicated for head and whole body X-ray computed tomography applications. Indications For Use of GE LightSpeed™ ACT FP16 when configured as a Fluoroscopic System: . GE LightSpeed™ ACT FP16 is indicated for use in generating fluoroscopic images of SE Elghtopeda. nonedures, and optionally, rotational imaging procedures. It is intended to replace procedures, and optionally, rethnology image intensifier technology and is not intended for mammography applications.

The GE LightSpeed ACT FP16 is a modified CT system intended to be located in close proximity to a GE Innova 4100 Single Plane Digital Fluoroscopic Imaging system utilizing a single patient table which can be configured for interventional x-ray or CT imaging procedures. This modification allows the patient to remain on the x-ray table which can be quickly configured for CT scanning via a movable gantry. Both the CT and X-ray systems are used separately, one at a time, in accordance with their respective indications for use.

The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16/ LightSpeed Xtra) 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), and Gated acquisitions for all ages. 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 LightSpeed RT18 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT18/ LightSpeed Xtra) is indicated for head, whole body, 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 system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40). When used in the LightSpeed RT16 configuration, the system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

The GE LightSpeed RT16 / LightSpeed Xtra V2 (aka LightSpeed RT16 /LightSpeed Xtra CT) CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated 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 0.5 seconds (at full) per rotation, and can acquire up to 16 slices of data per rotation with a maximum total coverage of 20mm in the axial direction. The system can be operated in Axial, Cine, Helical, Fluoro and Gated acquisition modes. The GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.

The new Bolus Chasing is offered as an option for Innova 4100 and 3100, already cleared under K033244 and K031637.

Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

Senographe Stereo is an option of Senographe DS composed of the following elements: - A stereotactic positioner . - Display and stereo positioning software of the Senographe DS . - A lateral arm for the lateral approach procedures . - A vertical adapter for vertical approach procedures using a vacuum assisted . device

The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications. The new tilt table will support performing procedures like CO2 studies. Venography.

The new tilt table is offered as an option for Innova 4100, in place of the existing Omega V table, which is part of the Innova 4100 system already cleared under K023178.

The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.

The GE 1.5T 8 Channel Torso Coil is a 12 element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. The device utilizes technology similar to the GE 8 Channel Cardiac Phased Array Coil (K022669), but is designed to image the torso, similar to the GE 3.0T Torso Phased Array Coil (K030495).

CT Colonography is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of supine & prone data sets, and an object oriented endoluminal display. In comparison to colonoscopy, this tool has an advantage of depth penetration due its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies.

CT Colonography is an image analysis software package that includes all the required software that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both. CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for Colonography, CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. Colonography, CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.

The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.

The GE 3.0T General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to increase the field strength from 1.5T to 3.0T. In addition, two passive blocking networks are added to improve reliability and patient safety.