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The device is intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm.

The Wrist Blood Pressure Monitor is a reusable, active, non-sterile, non-invasive and non-implantable device for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm. It is a home-use device prohibited from use in MRI (magnetic resonance imaging) environment. This device has the systolic and diastolic display features. The device is of the watch type and powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 300mmHg. Product includes device (preinstalled with a strap and large-sized cuff: 16.6-21.0cm), strap with a medium-sized cuff: 13.0-16.5cm, wrist measuring tape, charging base (with the power cable). The product functional configurations of OHMS11 and OHMS12 are completely identical, and the difference between the two is reflected in the color (OHMS11 is the dark gray color, OHMS12 is the champagne color).

Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information. Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed. Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants.

Ashvins is a modular software solution and is used for viewing, reporting, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammoqraphic images and bio-signals, as well as findings and demographic information. Ashvins also collects, manages, and distributes patient-related and device-related information. Ashvins offers advanced image processing functions such as multiplanar reconstruction, 3D reconstruction and measurement functions. Ashvins does not utilize artificial intelligence or computer-aided diagnosis to identify abnormalities in medical images or to assist in diagnosis. For primary image diagnosis in Mammography only uncompressed images and only preprocessed DICOM *For Presentation" images must be used. Existing regulatory or legal require-ments regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed. Ashvins is designed to be used by trained professionals, including but not limited to physicians, radiolo-gists, ophthalmologists, nurses, medical technicians, and assistants. Ashvins integrates systems including, but not limited to, devices and information systems for medical practices and hospitals (such as radiology and/or ophthalmology information systems, etc.) in accord-ance with international standards. Ashvins also provides manufacturer-specific interfaces for other sys-tems/devices. Ashvins offers the possibility of capturing and digitizing documents such as PDFs, single images, image sequences and film sequences, as well as converting and archiving them in DICOM format. As such, Ash-vins serves as a manufacturer-independent image management system and archive, a so-called "Vendor Neutral Archive." Ashvins also provides functions for the collection, processing, and transfer of medical and administrative data in hospitals or medical practices, including billing functions. Ashvins allows the visualization and statistical evaluation of meta data provided by the devices. Ashvins is used at a physician's workplace to assist the physician with diagnosis and treatment planning, but the product itself does not generate an automated diagnosis, findings, or a treatment plan. The final decision regarding the diagnosis always remains with the physician or the medical staff within their own decision-making area. Ashvins is offered in different variants with different ranges of functions for different application areas depending on the configuration (for further information see document "General Description of Product Vari-ants").

CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.

The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)). The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product. CPI RAD VISION is a component of a complete radiographic x-ray system.

The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems. The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities. The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION will not include the X-Ray system itself.

The CPI RAD VISION is a component of a complete radiographic x-ray system. The CPI RAD VISION provides a single user interface for control of the x-ray generator and all digital imaging functions required by a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images). The CPI RAD VISION consists of Flat Panel Detector, ISO-BOX (Medical Grade Isolation Transformer), LCD Monitor, and a workstation (computer) with x-ray generator interface, image receptor interface, and network port for communications with supported DICOM devices.

The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The CPIVision Digital Imaging system allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. The CPIVision Digital Imaging system enables the operator to hardcopy image with a laser printer or send images over a network. The major system includes: a fluoroscopic CCD camera/lens, monitors, and an image processor.

The CPIVision Digital Imaging system allows the use of digital imaging to be applied to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camera/lens on the output port of the image intensifier and digitizing the video output on the image intensifier. The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Network Storage Provider. The image can also be computer processed, including brightness and contrast, edge enhancement, zoom, and subtraction. The CPIVision Digital Imaging enables the operator to hardcopy image with a laser printer or send images over a network. The major system components are: a fluoroscopic CCD camera/lens, monitors, and an image processor.

ViTelCare™ C-Turtle Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, self-assessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The healthcare practitioner can contact the patient directly through a videoconference connection when desired. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.

The ViTelCare™ C-Turtle Patient Monitoring System is a PC based Telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.

The intended use of the Stryker Visum™ LED Surgical Lighting System is to illuminate the operative site during surgical procedures with high intensity light.

The Stryker Visum™ LED Surgical Lighting System is intended to illuminate the operative site during surgical procedures. Light functions can be controlled from within the sterile field, from a wall mounted control panel, or through the Stryker SIDNE™ device (K022393). The Stryker Visum™ LED Surgical Lighting System will be used in indications the same as other surgical lights currently offered for commercial distribution in the United States. The Stryker Visum™ LED Surgical Lighting System is suitable for all major and minor surgical procedures throughout the hospital. The light moves via an easy to move pivoting suspension and has a completely sealed lighthead for safety and hygiene. Intensity is variable from 50,000 Lux to 160,000 Lux and each lighthead has redundant light sources that are not affected by individual source failure. The light quality is based upon a multiple reflector design combined with a heat removing conductive path to provide shadow free, cool light. All systems are ceiling, wall, or mobile mounted lights and each provides sufficient illumination for all types of surgical procedures. The ceiling mounted lights are available in single, dual, and triple configurations and may also be combined with a separate arm to hold a viewing monitor.

The CIVNET CIV-ob software application is intended for automatic fetal monitor patient data management. The application does this by: a) Displaying on-line fetal heart rate and TOCO data received from the patient Displaying on mic recar near representation as it is displayed on the fetal monitor paper printout. b) Providing the means to control and display multiple beds simultaneously. c) Providing automatic Archiving of the data. c) Frovide the ability to interface with different fetal monitors operating with the same interface protocol. e) Easy interfacing with any IT patient record system for data acquisition, viewing and storage of electronic patient record. f) Provide visual notification of when acquired fetal monitor heart rate exceed I to ride visual nothlous for high and low fetal heart rate and poor signal quality. g) Providing the ability to record, with patient record, fluid input and output information that is defined by the user. h) Providing the ability to archive files to a secondary or tertiary storage medium (i.e. optical disk). Providing the ability to print (locally or remote) patient records. i) i) I roviding the ability to review fetal monitor data remotely over the TCP/IP

The CIVNET CIV-ob is a software application that is intended for use as a clinical data management system (also referred to as a clinical information system - CIS). The function of the system is the management of fetal and maternal vital heart rate and uterine vital signs clinical data automatically acquired from a bedside fetal monitor, for the purpose of providing, ready and organized access to patient and/or clinical data that would normally be provided on paper records and/or separate clinical systems/devices. The CIV-ob serves as an electronic medical record. The CIV-ob operates with off-the-shelf software and hardware. The device is intended for use in a hospital/clinical environment.

ViTelCare™ Turtle 400 Patient Monitoring System is intended to be a communication tool for an in-home patient that acquires, accumulates, and transmits vital signs information, selfassessment of physical condition, and other physiological data to a healthcare practitioner located remotely from the patient. The patient information is received and stored on the MedVizer™ ViTelCare Call Center where a qualified healthcare practitioner can review the patient information and data. The communication connectivity between patient and healthcare practitioner is via a standard public telecommunications utility to the Internet. Decisions concerning diagnosis and treatment are to be performed by qualified healthcare professionals.

The ViTelCare™ Turtle 400 Patient Monitoring System is a PC based Telemedicine system adapted to the collection, management, and communication of patient monitoring data from home and group care environments.

The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room. The intent of the Switchpoint Infinity™ Control System is to allow operating room personnel a center point for controlling all equipment and communication in surgery. The Stryker Switchpoint Infinity™ Control System is indicated for use with the Stryker Endoscopy Sidne™ System [510(k) # K022393] and Sidne™ compatible endoscopic and general surgery devices. The users of Switchpoint Infinity™ Control System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, urologists, and any other surgeon whom requires the use of voice, video, or control in the operating room or a teleconferencing interface.

The Switchpoint Infinity™ Control System is a medical device that is designed to allow direct control of the state, selection, and settings of room equipment, and audio/video equipment and indirect control through the Stryker Endoscopy Sidne™ System of the state, selection, and settings of surgical equipment in the operating room. The Switchpoint Infinity™ Control System is also an integrated voice, video, and data router and teleconferencing interface for the operating room.