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Medical purpose EP navigator is intended to provide navigation support for intra-cardiac instruments, such as catheters and guidewires, during the interventional treatment of heart rhythm disorders, by overlaying acquired and segmented 3D anatomical image data over live fluoroscopic X-ray images of the same anatomy. EP navigator is intended to enable users to segment previously acquired 3D CT or other datasets and overlay and register these 3D segmented data sets with live fluoroscopy X-ray images of the same anatomy in order to support catheter/device navigation. The 3D segmented data set can be displayed with a color map annotation received from an external source.

EP navigator image software processing algorithms are executed on a PC based hardware platform, which can perform the following functions: - segment previously acquired DICOM 3D CT or other image data.(the acquisition of . the image data from a rotational angiogram is known as 3D atriography (3D ATG)) - superimpose the segmented 3D CT or other dataset on a live fluoroscopic X-ray image of the same anatomy, obtained on a Philips Allura Xper FD angiography X-ray system, - . register the segmented 3D CT or other data with live fluoroscopic X-ray images obtained on a Philips Allura Xper FD angiography X-ray system for specified procedures. - The 3D segmented data set can be displayed with a color map annotation received ● from an external source. - position visual markers on the 3D volume ● - visualize the inside of the 3D volume (EndoView) . - certain buttons on the user interface control EP Logix functions; ● - visual marker positions are transmitted to EP Logix; . - color map information is received from EP Logix. .

As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Detector is combined with a Philips XD-S workstation (K063781) which consists of a computer, keyboard, display, mouse. The complete X-ray system would further include other Philips subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. The XD-S workstation and the complete X-ray systems are not changed other than by replacing an Xray receptor with the Wireless Portable Detector FD-W17.

The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies, within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: - Orthopedic Neuro Abdominal Vascular Thoracic Cardiac

The Veradius device is a Mobile C-arm X-ray System designed for medical applications during diagnostic, interventional and surgical procedures. The device consists mainly of two parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, mains control unit, an user interface for image/patient handling and optionally an integrated workstation). All movements of the C-arm stand are manual except the height movement. The Mobile viewing station can be used standalone for reviewing and archiving purposes,

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility.

The SureSigns VS2 Vital Signs monitor and the SureSigns VM1 are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitors may be used in transport situations within a healthcare facility. The addition of the wireless functionality to the predicate VS3 does not change the intended use or indications for use. The subject devices have the same fundamental technological characteristics as the legally marketed predicate devices. The subject devices use the same design as the predict device. The composition of the VS2 and the VM1 materials are different than the predicate device, however are made of a material previously used in other medical devices. The chemical composition of the subject devices has changed but is the same as material used in other predicate devices. The energy source of the subject device the VS2 is an external power supply, while the VM1 will use a power supply that is the same as the predicate device. The VS2 and the VM1 both can run on battery power with batteries similar to the predicate devices.

As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.

The Philips XD-S is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data, and to generate, process and handle digital X-ray images. As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography. The complete X-ray system would further include other subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in patient transport and healthcare environments.

The modification creates the Masimo SET SpO₂ pulse oximetry module for use in Philips host patient monitors.

The BV Pulsera system is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients except babies, within the limits of the systems. The system is to be used in health care facilities both inside the operating room, sterile as well as non-sterile environments, with a variety of procedures. The 3D-RX functionality on the BV Pulsera provides 3D imaging and intended to be used whenever the physician benefits from intra-operatively-generated 3D information of high-contrast objects and anatomical structures. The 3D application areas for the BV Pulsera are: - Skull (Ear Nose and Throat, Maxillo Facial) - . Cervical spine - . Fore arm - Elbow . - Hand /Wrist ● - . Knee - Lower leg ● - Foot / Ankle . The *3D-RX* Option on the BV Pulsera provides 3D imaging functionality and is intended to be used whenever the physician benefits from intra-operated 3D information of high contrast objects and anatomical structures.

The Philips 3D-RX Option for BV Pulsera is a mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques, which extends the functionality of the BV Pulsera Release 2.2 with 3D imaging. Using the 3D-RX Option on the BV Pulsera, an operator another a rotation run to acquire images. These images are used by an integrated 3D workstation which creates a 3D reconstruction, and which provides tools for further processing and analysis. Both hardware and software additions are added to the BV Pulsera C-Arm X-Ray System to produce the 3D-RX Option.

Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology. Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams. Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols. Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components. The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving / review / analysis/ quantification / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology, Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3th party programs from the user interface (Desktop Integration). It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams. Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols. Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

XperCT is a software option on the Allura Xper product family intended for imaging bone, soft tissue and other body structures. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up.

XperCT is a software option on the Allura Xper product family. It reconstructs 3D volumes from rotational fluoroscopy acquisitions, and provides CT-like images.

FLXIS is intended to visualize anatomical structures by converting a pattern of Xradiation into a visible image through electronic amplification.

FLXIS is a family of image detection components including image intensifiers, a camera, an image processing functionality and a remote control user interface, of which several an inage probeconfigured. Each configuration can be delivered with a display module.