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510(k) Data Aggregation

    K Number
    K143474
    Device Name
    Artemis Hand Held Imaging System
    Manufacturer
    QUEST MEDICAL IMAGING
    Date Cleared
    2015-06-30

    (207 days)

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

    QUEST MEDICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries. The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.
    Device Description
    The Artemis Handheld System is intended for intraoperative and minimal invasive visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue. The Artemis System consists of a hand held camera, Artemis Fast Lens; ring light for open procedures, and a laparoscope for minimally invasive procedures, controller (lap top) and a light source or Light Engine. The Artemis Light Engine (K141164) is Class II device for illumination of surgical sites for diagnostic purposes. The light Engine has imaging capabilities for fluorescence as well. The laparoscope is an OEM item branded for Quest and cleared via 510(k) Number K945266.
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    K Number
    K141164
    Device Name
    ARTEMIS LIGHT ENGINE
    Manufacturer
    QUEST MEDICAL IMAGING
    Date Cleared
    2015-03-16

    (315 days)

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

    QUEST MEDICAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
    Device Description
    The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).
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