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510(k) Data Aggregation

    K Number
    K153416
    Device Name
    ArcScan Insight 100
    Manufacturer
    ARCSCAN, INC.
    Date Cleared
    2016-02-02

    (69 days)

    Product Code
    IYO, ITX
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARCSCAN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ArcScan Insight 100 is indicated for use in adults to measure dimensions of the human eye. To provide tomographic, high-resolution ultrasound images of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle-to-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.
    Device Description
    ArcScan Insight 100 is a precision ultrasound device for imaging and biometry of the eye. It uses a 20-60 MHz transducer that scans the eye in an arc whose curvature approximates the anterior ocular surfaces. Specifically, the ArcScan Insight 100 can measure the thickness of the cornea and its individual layers, the epithelium, stroma, and surgically induced surfaces. Measurements can also be made of the anatomic structures comprising the anterior of the eye such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width. Measurements can be made of pathologic structures such as solid masses and cysts.
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