BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)

    K Number: K242314 · Decision Sep 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    2
    Review Days
    402

    Basic Information

    Device Name
    Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2)
    K Number
    K242314
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Augment Intelligent Medical System (China) Co., Ltd.
    Date Received
    August 5, 2024
    Decision Date
    September 11, 2025
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by Augment Intelligent Medical System (China) Co., Ltd.

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    K221499 Minimally Invasive Prostate Surgery Navigation System