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CT Collaboration Live is indicated for remote communication with CT console (via chat, call, video call, screen sharing and remote access) by a qualified remote clinical user for consultation, guidance, support, and training in real time. Remote access must be granted by the CT technologist operating the system. Remote access is only available for Philips CT systems supporting CT Collaboration Live connectivity capabilities. Images reviewed remotely are not for diagnostic use.

The proposed CT Collaboration Live is a software application integrated in Philips Computed Tomography (CT) X-Ray CT 5300 Systems. CT Collaboration Live enables two-way communication of text, voice, image, and video information between a CT system operator and a remote user on a Windows device. CT Collaboration Live facilitates: 1) peer-to-peer consultation and training, 2) system-level remote sharing & operation, 3) access to live image feed and 4) remote expert user(s) and physician consultation. CT Collaboration Live functionality includes a remote-control feature in which the CT system operator may grant a qualified remote user control of the CT system parameters via a virtual control panel and virtual touch screen.

The CT 5300 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 CT 5300 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 etther 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 device is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry 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. This system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. The CT 5300 has a 72 cm bore and includes a detector array that provides 50 cm scan field of view (FOV). The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed device have the same fundamental design characteristics and are based on comparable technologies as the current marketed predicate Philips Incisive CT K212441(April 27, 2022). The key system modules and functionalities are: 1. Gantry The Gantry consists of 4 main internal units: a. X-Ray Tube – produces X-rays necessary for scanning. b. High voltage generator - produces high voltage power supply to X-ray tube, consists of system Interface Unit, Power Block Unit and Anode Drive Unit. c. A-plane: adjusts the slice thickness during axial scan and monitor the changes of X-ray. d. DMS (Data Management System) – absorbs X-ray radiation by detectors and converts it to digital readout. 2. Patient Table (Couch) The Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. 3. Console The console is used to operate the system and monitor the scan. The Operator console includes a computer, monitors and CTBOX. 4. CT on Trailer Kit The CT 5300 installed and secured on a trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. Besides being installed in hospital, the CT may also be installed on trailer to be transported to designated locations for use within a professional healthcare environment. The CT 5300 on Trailer Kit has the same fundamental design characteristics and technologies as the current marketed Philips Incisive CT on trailer (K211168 - November 22, 2021). The CT on Trailer configuration is identical to the K211168 trailer configuration. The CT system should only be used in designated locations for use with appropriate radiation controls and safety measures. In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images. Upgrades Kit is available to upgrade earlier Incisive CT installations to latest version.

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician. The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or right knee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, an anterior and a posterior part. Positioning pads are also supplied to support comfortable positioning. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil is used independently and cannot be combined with any other coils. This coil is available for 3.0T MR systems and is compatible with Philips 3.0T MR Scanners.

The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician. The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.

The proposed of Smart Fit Shoulder 1.5T and Smart Fit TorsoCardiac 1.5T are intended to be used in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional images of the internal structure of the head, body, or extremities, in any orientation. These images, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The proposed Smart Fit Torsocardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of the torso (including chest, abdomen, pelvis), head and neck and heart. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed- board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body. The proposed Smart Fit Shoulder 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Anterior-Posterior direction for patient shoulder scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the Head-Feet axis are also at the outer surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.

The Philips CT 3500 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 Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) 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 proposed Philips CT 3500 is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry 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. This system also includes signal analvsis and display equipment, patient and equipment supports, components, and accessories. The Philips CT 3500 has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). Besides installed in hospital, the proposed Philips CT 3500 may also be installed on trailer and be transported to designed locations for use. And Philips CT 3500 installed on trailer has the same intended use as installed in hospital. The key components that are used in the proposed Philips CT 3500 have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT (K212441 - April 27, 2022). CT on Trailer Kit that is used in the proposed Philips CT 3500 to install and secure the CT system on trailers have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT on trailer (K211168 - November 22, 2021). Trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. The key system modules and functionalities are: 1. Gantry. The Gantry consists of 4 main internal units: a) X-Ray Tube – produce X-ray necessary for scanning. b) High voltage generator - produce high voltage power supply to X-ray tube. consists of system Interface Unit, Power Block Unit and Anode Drive Unit. c) A-plane: adjust the slice thickness during axial scan and monitors the changes of X-ray d) DMS (Data Measurement System) – absorb X-ray radiation by detectors and convert it to digital readout. 2. Patient Table (Couch) Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. 3. Console It is used to operate the system and monitor the scan. The Operator console includes computer, monitor and CTBOX. 4. CT on Trailer Kit Philips CT 3500 installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. CT on Trailer Kit is used to install and secure the CT system on trailers, trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images.

The Incisive 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 Incisive 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 proposed Philips Incisive CT is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry 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. This system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Ingenuity CT (K160743, 08/08/2016). 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 - Containing a Host computer and display that is the primary user interface. In addition to the above components and the software operating them, each system includes 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 Magnetic Resonance (MR) coil is used with a Philips 1.5T MR scanner. A trained physician interprets the diagnostic images (of the anatomy of interest) produced.

The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician. The proposed dS TorsoCardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of torso, cardiac, and neck. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body. The proposed dS MSK S 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of wrist, foot-ankle, and elbow. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body. The proposed dS MSK M 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder, knee, hip, foot, and elbow. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body. The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used with the Philips 1.5T MRI Scanners.

The Incisive 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 equipments and accessories. The Incisive 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. Besides installed in hospital, the proposed Philips Incisive CT may also be installed on trailer and be transported to designated locations for use. And Incisive CT installed on trailer has the same intended use as installed in hospital.

The proposed Philips Incisive CT on Trailer is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry 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. This system also includes signal analysis and display equipment, patient and equipment support, components, and accessories. The Philips Incisive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). Besides installed in hospital, Philips Incisive CT can also be installed on trailer and be transported to designated locations. The main components (detection system, the reconstruction algorithm, and the x-ray system) that are used in the proposed Philips Incisive CT on trailer are identical to the currently marketed and predicate Philips Incisive CT (K180015, 20/March/2018). The components of the proposed Philips Incisive CT on trailer include the following: 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 - Containing a Host computer and display that is the primary user interface. 4. CT on Trailer Kit - Modified Incisive CT installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. In addition to the above components and the software operating them, each system includes 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 Precise Position is intended for use with Philips Incisive CT systems. The following guided workflow. - Patient orientation identification - Surview range recommendation - Automatic centering the patient anatomy - Provide visual images of patient on the table Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies. Patient population limitation: Patient younger than 16 years are not supported.

Precise Position is an optional feature to assist user for position the patient before the body examination such as CT scan. The purpose of this feature is to reduce the patient position time via the camera detection and calculation result. It includes automatic detect patient orientation, patient anatomy scan range and center of patient anatomy. Precise Position including a camera with both color and depth function is installed in the ceiling of the scan room, in such a way to cover the entire patient on the patient table. The camera control and image data transmit via the high speed fiber and copper hybrid USB cable. The power supply of the camera is from the gantry. Precise position adopts the AI algorithm (Convolution Neural Network) to detect the joints of the patient body, and then identify surview start/end position and patient orientation. The algorithm can also support detect center of patient anatomy. Limitation for Precise Position There is no limitation for Precise Position except below items: • Patients below the age of 16 are not supported. • Decubitus orientations are not supported. The Precise Position display results may get affected by the following conditions: • When the patient is covered by sheet, blanket etc., • When the patient is not completely covered by the ceiling camera view, e.g. blocked by the gantry or out of camera's FOV etc. • When the patient is wearing clothes that reflects light, e.g. plastic-like clothes. • When the patient is wearing black clothes. • When the patient is wearing thick clothes. • When there are other people around the patient.

The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

The DuraDiagnost is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.