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The Philips CT Big Bore 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. These systems are indicated for head and whole body X-ray Computed Tomography applications in oncology, vascular and cardiology, for 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 CT Big Bore is currently available in two system configurations, the Oncology configuration and the Radiology (Base) configuration. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the Philips CT Big Bore 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 detector 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 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.

This device is a diagnostic imaging system for that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: · The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders. · The detection, localization, and staging of tumors and diagnosing cancer patients. · Radiation therapy treatment planning and interventional radiology procedures. The system includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for the quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner. This scanner is also 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 proposed Ingenuity TF is an integrated diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within head, body and total body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional images of biochemical and metabolic processes of organs within the body. The Ingenuity TF utilized Time-of-Flight (ToF) technology for the PET reconstruction. CT is a medical imaging technique that uses Xrays to obtain cross-sectional images of the head or body. The system utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The CT component can be utilized by clinicians for lung cancer screening. As such, lung cancer screening has been added to the Ingenuity TF intended use. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease. The major subsystems of the PET/CT include the PET image reconstruction subsystem, the PET Data Acquisition subsystem, the CT Image reconstruction subsystem, the CT acquisition subsystem, the PET Gantry, the CT Gantry and the patient table. The system is suitable for all patients, infant through adult.