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510(k) Data Aggregation

    K Number
    K131596
    Device Name
    WOUND MEASURING & MONITORING DEVICE
    Manufacturer
    WOUNDVISION, LLC
    Date Cleared
    2013-12-11

    (191 days)

    Product Code
    FXN
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FXN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data. Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device. The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional. The Scout does not provide a diagnosis or therapy.
    Device Description
    The Scout is a combination digital camera and long-wave infrared camera. The clinician simultaneously captures a visual and infrared image that can be uploaded and stored with a patient's electronic medical record. Body surface size and thermal intensity data can be measured and recorded. The digital camera captures the visible light wavelengths from the electromagnetic spectrum that is visible to the human eye. The infrared camera captures the infrared radiation emitted by the human body from the electromagnetic spectrum that is not visible to the human eye. Both cameras are housed in a plastic casing which transmits captured data to a PC.
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    K Number
    K130165
    Device Name
    PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
    Manufacturer
    ADVANCED PLANIMETRIC SERVICES, LLC
    Date Cleared
    2013-08-30

    (219 days)

    Product Code
    FXN
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FXN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PictZar is indicated for wound measurement and documentation and can be used on all external wound types.
    Device Description
    PictZar® is digital planimetry software used for the measurement and tracking
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    K Number
    K070426
    Device Name
    SILHOUETTE, MODEL 1000.01
    Manufacturer
    ARANZ MEDICAL LIMITED
    Date Cleared
    2007-06-29

    (136 days)

    Product Code
    FXN
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FXN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.
    Device Description
    Silhouette consists of a camera connected to a PDA, for the measurement and tracking of wounds
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    K Number
    K962148
    Device Name
    VERGE VIDEOMETER
    Manufacturer
    VERG, INC.
    Date Cleared
    1996-12-20

    (200 days)

    Product Code
    FXN
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FXN

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

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