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510(k) Data Aggregation

    K Number
    K234090
    Device Name
    EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)
    Manufacturer
    SurgVision GmbH
    Date Cleared
    2024-03-20

    (89 days)

    Product Code
    IZI, OWN
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurgVision GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older. Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
    Device Description
    EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files. The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions.
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    K Number
    K222240
    Device Name
    EXPLORER AIR® II
    Manufacturer
    SurgVision GmbH
    Date Cleared
    2023-02-28

    (217 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurgVision GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older. Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
    Device Description
    EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760mm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.
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    K Number
    K214097
    Device Name
    Explorer Air II
    Manufacturer
    SurgVision GmbH
    Date Cleared
    2022-02-25

    (59 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurgVision GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.
    Device Description
    EXPLORER AIR® II is a fluorescence imaging system, which enables users to visually assess blood flow to evaluate tissue perfusion and tissue-transfer circulation. It can be used on any part of the body during plastic, reconstructive, gastrointestinal, and organ transplant surgeries. EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band centered around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.
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