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510(k) Data Aggregation

    K Number
    K102027
    Device Name
    AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
    Date Cleared
    2010-12-22

    (156 days)

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

    QUANTEL MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: - Axial Length measurement of the eye by ultrasonic means. - Implanted IOL power calculation, using the Axial Length measurement. .
    Device Description
    The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.
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    K Number
    K102198
    Device Name
    COMPACT TOUCH STS
    Date Cleared
    2010-11-05

    (93 days)

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

    QUANTEL MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including: ◆ Visualization of the interior of the eye by B scan ◆ Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
    Device Description
    The COMPACT TOUCH STS is an ultrasonic system designed for ophthalmic use. It performs B type scans for diagnostic imaging of the eye. It is not intended to be used for determining the power of implanted lenses, but rather is capable of making intra-ocular measurements. The system is composed of a main console controlled by a touch screen. It uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer.
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