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510(k) Data Aggregation

    K Number
    K243296
    Device Name
    Disposable Biopsy Needle
    Manufacturer
    Carbon (Shenzhen) Medical Device Co., Ltd.
    Date Cleared
    2025-07-11

    (266 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carbon (Shenzhen) Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243298
    Device Name
    Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
    Manufacturer
    Carbon (Shenzhen) Medical Device Co., Ltd.
    Date Cleared
    2025-04-03

    (167 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carbon (Shenzhen) Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is applicable for adults. It is intended for use in abdominal, superficial organs, trans-rectal, musculo-skeletal, peripheral vessel, urology exams. Modes of operation include: B, B+C, B+C+D(PW), B+M Mode, Image fusion, Needle Line. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display of the human body and fluid, which is intended to be used in a hospital or medical clinic.
    Device Description
    Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is a medical, real-time, high-resolution ultrasound diagnosis system. It has a 24" multi-directional swiveled (non-touch) LCD monitor, a secondary 17" touch-display and cart. The System offers B, C, D, M Mode, as well as FUSION Mode which could synthesis real-time US images and preoperative images, such as CT and MRI. It could be equipped with convex-array, linear-array and intracavitary tracked probes, that supporting a wide range of clinical applications.
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