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510(k) Data Aggregation

    K Number
    K021290
    Device Name
    VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2002-06-28

    (66 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista Visualization System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures
    Device Description
    The Vista Visualization System is used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures including bariatric surgeries. The system consists of the Vista StereoScope System (camera head, endoscope and a camera control unit), and the Head Mounted Display System (HMD with HMD processor). The system is designed to work with commercially available light sources, light guides, and video monitor displays.
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    K Number
    K020301
    Device Name
    MODIFICATION TO VISTA STEREOSCOPE SYSTEM
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2002-02-12

    (14 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista StereoScope System is intended for the use in endoscopic procedures and all types o video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior an posterior spinal and as an aid in visualization of cardiac structures
    Device Description
    The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system is supplied as a Vista Stereoscope Camera Head, Vista Stereo Endoscope and a 3 D Camera control unit (CCU). The device is designed to work with commercially available light sources and video monitor overhead mounted displays. The modified coupler enables the camera head assembly to be sterilized.
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    K Number
    K991303
    Device Name
    VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-07-12

    (87 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users' head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.
    Device Description
    The Vista ORPC System with IntraOp software now features the capability to control the image display with auxiliary input devices such as a touchscreen, mouse/touchpad, and a remote keypad, as well as with voice control. Color, hue, contrast and brightness for the video sources are now adjusted via the auxilliary input devices. Another new feature of the device is the capability to capture intra-operative static images of what is being displayed on the HMD. The last captured image can be displayed to the HMD as a picture-in-picture for review. The captured images can also be exported to a CD data storage disk via a CD-RW device. The capture and display last capture functions can be operated via voice control or the auxilliary input devices. The export feature is controlled via mouse, or the touchscreen. The system also allows the VGA monitor to display what is being seen in the HMD or the user interface controls on the desktop.
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    K Number
    K990635
    Device Name
    VISTA STEREOSCOPE SYSTEM
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-05-19

    (82 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista StereoScope System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures.
    Device Description
    The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system will be supplied as a Vista StereoScope Camera Head, Vista Stereo Endoscope and a 3D Camera Control Unit (CCU). The device is designed to work with commercially available light sources and video monitors or head mounted displays.
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    K Number
    K973436
    Device Name
    VISTA HEAD MOUNTED DISPLAY
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-12-09

    (90 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista Head Mounted Display System is designed to display video images while mounted on the users head.
    Device Description
    Not Found
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    K Number
    K971373
    Device Name
    VISTA SINGLE CHIP VIDEO CAMERA
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-05-20

    (36 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in all types of endoscopic and endoscopic assisted procedures. The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.
    Device Description
    The Vista Single Chip Video Camera is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.
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    K Number
    K970217
    Device Name
    VISTA ILLUMINATION SYSTEM
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-04-02

    (71 days)

    Product Code
    FFS
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista Illumination System is intended to provide visible light for illumination of various rigid and flexible endoscopes, laparoscopes, cameras, and headlamps age. "It is intended for use in all types of endoscopic and endoscopic assisted procedures, as well as visualization of the evacuated cardiac chamber.
    Device Description
    The Vista Illumination System, is a Xenon Light Source illumination system consisting of a light source unit which houses the lamp and a fiberoptic cable. The system provides visible light for illumination of rigid or flexible endoscopes, laparoscopes, video cameras, headlamps,etc. The light source has 2 ports which are provided with independent attenuator controls and separate light output intensity level indicators. The front panel contains dual intensity level indicators as well as system fault and lamp fault LED's. The LED's will light if the lamp fails to start or fails during use for any reason. There is a LCD on the front panel that provides an indication of lamp life. The fiberoptic cable produces a uniform beam profile from a single fiber. There are three different adapters to allow connection to various endoscopic devices currently available. The thread types are for Storz, ACMI and Wolfe. Custom adapters are available. The fiber is available in core diameter of 0.1mm to 1mm with a standard cable length of 10 feet.
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    K Number
    K961800
    Device Name
    HEAD MOUNTED DISPLAY
    Manufacturer
    VISTA MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-09-11

    (125 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISTA MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vista Head Mounted Display System is designed to display video images while mounted on the users head.
    Device Description
    The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion of the normal straight ahead field of view. This display is intended to be used as a component of a visualization system for use in endoscopic surgery. Traditional video-endoscopic surgery images are displayed on a TV monitor. This requires the surgeon to maintain contact with the traditional monitor and remain in position with it at all times. Having to turn away from the monitor causes the surgeon to lose sight of what is being accessed. The HMD system enables the surgeon to see the surgical site as well as the general operating field with the lateral and 45 degree look down vision, without having to look away, thus providing the means to present the endoscopic picture in a more natural and acceptable look down location with respect to the patient. This also provides a safe back up, the physician can resort to either direct visualization or utilize the back up 2D video monitor. The HMD takes a standard signal and displays it on two small electronic image display devices called liquid crystal display (LCD). It can be connected to any standard video generating equipment. The HMD consists of an image generating array, evepiece, and electronics. The image generating array is an active matrix liquid crystal display (LCD). These elements are mounted on a lightweight and compact headgear which fits comfortably on the user's head. The remaining electronics are housed separately in a controller station. The HMD communicates with the controller by a lightweight, durable, flexible cable. The HMD can be driven by both monocular and stereo endoscopes. The HMD Controller will accept NTSC, PAL with CVBS, or S Video (Y,C) video input. Interfaces to external and remote data sets, power supplies and drivers for the LCD and backlight are included in the controller. A maximum of four (4) HMDs and two (2) standard video monitors can be driven simultaneously with the single controller.
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