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510(k) Data Aggregation

    K Number
    K113832
    Device Name
    SONICEYE ULTRASOUND TRANSDUCER
    Date Cleared
    2012-03-06

    (70 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    BLACKTOE MEDICAL III, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SonicEye® ultrasound transducer is a general-purpose transducer intended for use by a qualified clinician for diagnostic ultrasound imaging or fluid flow analysis of the human body in the following applications: Pediatric, Small Organ (breast, thyroid, testicles, prostate), Musculo-skeletal (conventional and superficial), and Peripheral Vessel.
    Device Description
    The SonicEye® is a finger-mounted ultrasound transducer designed to attach to the SonoSite MicroMaxx® ultrasound system, in place of the SonoSite SLA/13-6 transducer, to acquire ultrasound images for display on the system. The SonicEye® transducer connects to the MicroMaxx® system's standard transducer port. Upon connection, the visual display on the MicroMaxx® system denotes that a type "SLA" transducer is in operation. The SonicEye® acoustic array is located in a small ring structure worn on the user's finger. The array is a linear type, with a 5-12 MHz frequency range, average scan depth of 3 cm and maximum scan depth of 6 cm. The array contains 128 elements spaced at 200 micron pitch, forming an azimuthal total aperture size of 25.6 mm. The elevational aperture height is 4 mm. The array supports acquisition of ultrasound images in 2D, M-Mode, Pulsed Wave (PW) Doppler, and Color Power Doppler, or in a combination of these modes.
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