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510(k) Data Aggregation

    K Number
    K972520
    Device Name
    OPTIVIEW
    Date Cleared
    1997-09-29

    (84 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIMED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OptiView is a digital image recording and display system for use in a cardiac cath lab or many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
    Device Description
    OptiView is a digital image recording and display system for use in a cardiac cath lab or many suite. It is a digital upgrade for the cardiac catheterization lab. It interfaces with new or existing systems to provide high quality diagnostic images and an instant increase in productivity. Integrated with the room's x-ray equipment OptiView acquires the flickered images from the video camera, gets rid of the flicker, and provides flicker-free live images displayed on a monitor in the cath lab and in the control room. The OptiView system records patient demographics and the images from the cardiac catheterization procedure (as well as radiography/fluoroscopy suite). The images on the screen can be enhanced to allow for easier, better diagnosis, and the images and the information can be reviewed during the case as well as after the case is completed.
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    K Number
    K955274
    Device Name
    BOOSTER LITE 3 MOTORIZED SCOOTER
    Date Cleared
    1996-11-04

    (355 days)

    Product Code
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIMED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955275
    Device Name
    BOOSTER TROPHY 5 MOTORIZED SCOOTER
    Date Cleared
    1996-11-04

    (355 days)

    Product Code
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIMED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K955276
    Device Name
    BOOSTER LITE 4 MOTORIZED SCOOTER
    Date Cleared
    1996-11-04

    (355 days)

    Product Code
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIMED TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

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