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The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes. DaTQUANT optional application enables visual evaluation and quantification of 131ioflupane (DaTscan™)) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 1231-ioflupane (DaTscan TM) images. These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease.

The Xeleris 3.1 is a Nuclear Medicine Workstation system intended for general nuclear medicine processing & review procedures for detection of radioisotope tracer uptake in the patient body, using a variety of processing modes supported by various clinical applications types and various features designed to enhance image quality. The components of the Xeleris 3.1 NM Workstation system are: operation console, monitor and peripherals. The Xeleris 3.1 is a modification of its predicate device Xeleris 3 while providing enhanced workflow to existing operations and enabling broader access to Xeleris applications in supporting PACS and GE AW Server and in offline client server configuration. Xeleris 3.1 also enables the use of normal data base comparison together with the quantification analysis of 123I-ioflupane brain NM images. Similar functionality for NM/PET brain image analysis also resides in the predicate devices K021656 and K123528.

The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.

Xeleris 3, as a modification of its predicate device - Xeleris 2 (K051673), is a Nuclear Medicine, PET, NM/CT, and PET/CT workstation. Xeleris 3, as a medical device, is computer workstation software used for the display, processing, archiving, printing, reporting and networking of NM, PET, NM/CT, and PET/CT studies. Xeleris 3 runs on Microsoft Windows XP based PC workstation (color monitor, keyboard, mouse, and CD-RW for archiving), an Ethernet network connection and system software. Optional DVD device is also available. Xeleris 3 also operates in client-server configurations. Xeleris 3 is classified as class II medical device, complies with voluntary Digital Imaging and Communication in Medicine (DICOM) standard.

The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system out would also be used by the plysician for staging of tumors, planning, guiding, and monitoring theram on the CE Discovery NMCT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, in inded to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Wolle body scanning) and tomographic mode (SPECT, Gated SPECT) The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contractions CT System: Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, nordiac and vascular X-Ray Computed Tomography applications NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion), The GE Discovery NM/CT 670 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to produce additional images, imaging planes, and analysis results. The system may be used fors pationts of all ages.

The Discovery NM/CT 670 system is a hybrid SPECT-CT system for performing nuclear cardiology medicine studies, CT studies or SPECT-CT hybrid studies wherein the SPECT and CT studies may be registered and displayed in a fused form on processing and review Workstation. The Discovery NM/CT 670 system is intended to allow healthcare facilities to carry out SPECT and CT studies using the same instrument Major parts of the hybrid system include the following parts : new NM Gantry with Dual detector heads , CT Gantry (same as BrightSpeed Elite (BSD16) gantry), new common patient table , Integrated operation Console including BSD16 operation console and NM operation console & BSD16 Power Distribution Unit .

The intended use of the GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion). The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of racer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications

The GE Discovery NM/CT 570c system is a back-to-back combination of the Ventri 1.1 SPECT scanner (K080124) and the LightSpeed 7.1 CT scanner (K061817), sharing a common LightSpeed 7.1 patient table. In addition to providing CT and SPECT standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the SPECT images and to facilitate localization of the emission activity in the patient anatomy.

The intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. Ventri 1.1 is primarily intended for cardiac applications.

The Ventri 1.1 is a high-performance Single Photon Emission Computed Tomography system, mainly for nuclear cardiology imaging.

The intended use of the VENTRi system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes. VENTRi is primarily intended for cardiac applications but also supports non-cardiac procedures of the patient's head, chest and body extremities.

The VENTRi is a high-performance dual-head Single Photon Emission Computed Tomography system dedicated mainly for nuclear cardiology imaging.

The intended use of the "Infinia LightSpeed" system is to perform: - General Nuclear Medicine imaging procedures for detection of radioisotope . tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications. - General Head & Body computed tomography (CT) applications. ◆ - Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation . correction imaging as well as functional and anatomical mapping imaging (registration and fusion).

The "Infinia LightSpeed" system is a combination of the Infinia NM Scanner (K022960 & K991841) and the "LightSpeed" 5 CT Scanner (K030420). In addition to providing CT and NM standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the NM images and to facilitate localization of the emission activity in the patient anatomy.

The intended use of the MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

The MyoLIGHT system is a dedicated Gamma Camera for nuclear cardiology, highperformance dual-head nuclear medicine imaging system. It is based on the following legally marketed device: CARDIOSPECT D90 - K021823. Modifications include reduced gantry size, adapted patient table, detectors moving in an enclosed space on a fixed radius and set at 90 degrees, integrated patient table, integrated acquisition station and operator console, and built-in cardiac gating circuitry.

The Photon Energy Recovery (PER) Option is intended for image quality and quantification improvement by scatter reduction in planar and tomographic nuclear medicine images. This option enables Gated SPECT acquisition in multi-energy window format which allows normal GSPECT processing along with PER scatter correction on the summed data. It can be used for acquisitions of single or multi-peak isotope as well as simultaneous multi-isotope images.

The Photon Energy Recovery (PER) option is a software application for reducing the Compton scatter contribution in nuclear images. This enables scatter correction of single as well as multipeak isotope imaging. In addition it allows for the correction of cross-talk down scatter in simultaneous multiisotope imaging. The method is based on a spectral deconvolution analysis using iterative recurrent linear regressions on nuclear spectra. These spectra are broken down into multiple energy windows. This submission provides an extension on the PER features of the currently legally marketed device, GE Vision Nuclear Medicine Workstation - K012568.

The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.

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