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The Philips iCT CT System is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipments and accessories. The iCT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The Philips iCT is currently available in two system configurations, iCT and iCT SP. Identical to the predicate, the Philips iCT CT System produces cross-sectional images of the body head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips iCT have the same fundamental design characteristics and are based on comparable technologies as the predicate. The main system modules and functionalities are: 1. Gantry. The Gantry has an aperture of 700mm and consists of the following internal units: a. Stator a fixed mechanical frame that carries hardware and software. b. Rotor A rotating circular stiff frame that is mounted in and supported by the stator. c. X-Ray Tube (XRT) and Generator fixed to the Rotor frame. The generator has a power rating of 100kW with optional 120kW. d. Data Measurement System (DMS) a detectors array, fixed to the rotor frame. The DMS provides 8cm of coverage (4cm for the iCT SP configuration) and up to 256 slices (128 slices for the iCT SP configuration).The gantry offers 0.3 second rotation time (with optional 0.27s rotation). 2. Patient Table (aka Couch or Support) carries the patient in and out through the Gantry bore synchronized with the scan. There are three available patient supports: a. Standard Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg) b. Bariatric Table provides maximum scannable range of 1750mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 650 lbs.(295kg) c. Extended Table provides maximum scannable range of 2100mm, longitudinal speed of 0.5mm/s-185mm/s and a maximum load capacity of 450 lbs.(204kg) 3. Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated powerful image reconstruction computer. 4. Monitors 5. Software features to view and analyze images.

The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset - composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures. The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

The IQon Spectral CT is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired xray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment; patient and equipment supports; components; and accessories. The IQon Spectral CT includes the detector array previously described in K133674 "Philips IQon Spectral CT". The IQon Spectral CT consists of three main components - a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the x-ray high voltage (HV) power supply, the x-ray tube, and the detection system. In addition to the above components and the software operating them, the system includes workstation hardware and software for data acquisition; and image display, manipulation, storage, and filming, as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

Pinnacle3® Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3® Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle3 Proton, which supports proton therapy planning. The full Pinnacle3® Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques. Pinnacle3® Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. Plans generated using this system is used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

The Pinnacle3® Radiation Therapy Planning System (hereafter Pinnacle3® RTP System) provides radiation treatment planning for the treatment of benign or malignant diseases. When using the Pinnacle3® RTP System, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. The Pinnacle3® RTP System can provide plans for various radiation therapy modalities including utilizing photon, proton, electron and brachytherapy techniques. The Pinnacle3® RTP System is a software package that runs on an Oracle Server and is accessed through one (or more) client(s) or an Oracle UNIX workstation. The software package consists of a core software module (Pinnacle3) and optional software features, which are available through a licensing scheme. The device has network capability to other Pinnacle® RTP System workstations, thin client, and to both input and output devices via local area network (LAN) or wide area network (WAN). Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. A qualified medical professional uses the Pinnacle3® RTP System for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan.

The Ingenuity CT is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. The Ingenuity CT is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information,

The Philips Ingenuity CT consists of three system configurations, the Philips Ingenuity CT, the Philips Ingenuity Core and the Philips Ingenuity Core128. These systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of Jung nodules that may represent cancer*. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips Ingenuity CT have the same fundamental design characteristics and are based on comparable technologies as the predicate. The main system modules and functionalities are: - 1. Gantry. The Gantry consists of 4 main internal units: - a. Stator a fixed mechanical frame that carries HW and SW. - b. Rotor A rotating circular stiff frame that is mounted in and supported by the stator. - c. X-Ray Tube (XRT) and Generator fixed to the Rotor frame. - d. Data Measurement System (DMS) a detectors array, fixed to the Rotor frame. - 2. Patient Support (Couch) carries the patient in and out through the Gantry bore synchronized with the scan. - 3. Console A two part subsystem containing a Host computer and display that is the primary user interface and the Common Image Reconstruction System (CIRS) - a dedicated powerful image reconstruction computer. In addition to the above components and the software operating them, each system includes a workstation hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Patient supports (positioning aids) are used to position the patient.

The Philips Multislice CT Systems are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment supports, components and accessories. The scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of protocols that have been approved and published by either a governmental body or professional medical society. *Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Philips Low Dose CT Lung Cancer Screening option can be used with Philips whole body multi-slice CT X-Ray Systems installed in a healthcare facility (clinic / hospital). These systems provide a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. Reconstruction algorithms available are standard reconstruction (filtered back projection), iDose 4 and IMR iterative reconstruction. These systems also include signal analysis and display equipment, patient and equipment supports, components and accessories. There are no functional, performance, feature, or design changes required for the qualified CT systems onto which the LDCT LCS Option is applied. Because none of the CTs will require hardware or software modifications, the Philips Low Dose CT Lung Cancer Screening option and the currently marketed and predicate Philips Multislice CT System for qualified CT systems in the installed base consists of: - A set of up to three reference LDCT LCS protocols: standard reconstruction, standard reconstruction with iDose 4, and with IMR iterative reconstruction (where applicable), for each qualified CT System on a per CT platform basis; - Detailed instructions on how to create the protocols on the corresponding CT System; and - A dedicated Instructions for Use for LDCT LCS that covers all qualified systems.

A nuclear medicine image display and processing application suite that provides software applications used to process, analyze and display medical images/data. The results obtained may be used as a tool, by a nuclear physician, in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure. The data processed may be derived from any nuclear medicine gamma camera. JETPack 2.0 should only be operated by qualified healthcare professionals trained in the use of nuclear medicine equipment.

JETPack 2.0 is a Windows®-based Nuclear Medicine suite of image display and processing applications for the Nuclear Medicine market segment. The software package is deployable on hardware platforms, which meet the minimum requirements needed to run the software. The comprehensive tools and features provided with this product, will allow the technologist and/or physician to perform image review, processing of source data, post processing, hardcopy production, interpretation, report . generation and contains the utilities necessary to support the workflow and data management between those activities.