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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 available in three system configurations, the Oncology configuration the Radiology (Base) configuration, and the new Sliding Gantry 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) supports the patient in a stationary position while the gantry moves in and out on a carriage. - 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. The Sliding Gantry Configuration provides the following features. - . The patient table is stationary during the scan. - . Patient is located on the stationary table. - To perform imaging, CT gantry rides on a carriage and moves over the patient.