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510(k) Data Aggregation

    K Number
    K202119
    Device Name
    AcuSee AS-P1000 System
    Date Cleared
    2020-10-07

    (69 days)

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

    Weipeng (Suzhou) Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AcuSee AS-P1000 system is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle and for predicting its future path on a display, which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization. The AcuSee AS-P1000 system is intended to be used in a clinical setting.
    Device Description
    The AcuSee AS-P1000 system is a medical device that tracks instrument positioning during ultrasoundguided procedures to provide instrument guidance to the end user. With accessories attached to the transducer probe and needle or needle-like rigid device, the AcuSee AS-P1000 system identifies and tracks the probe and the device within the field of view through optical detection technology. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The AcuSee AS-P1000 system is an accessory to any compatible ultrasound machine and transducer probe.
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