BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Prostate MR AI (VA10A)

    K Number: K241770 · Decision Mar 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    34
    Applicant Total
    31
    Review Days
    258

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    Basic Information

    Device Name
    Prostate MR AI (VA10A)
    K Number
    K241770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2090
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Healthcare GmbH
    Date Received
    June 20, 2024
    Decision Date
    March 5, 2025
    Product Code
    QDQ
    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
    QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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    Other Clearances by Siemens Healthcare GmbH

    K Number Device Name
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    K253057 AI-Rad Companion Brain MR
    K252838 MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
    K252608 AI-Rad Companion Prostate MR
    K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
    K242551 syngo Dynamics (Version VA41D)
    K242745 AI-Rad Companion Organs RT
    K240796 myAblation Guide (VB80A)
    Search all 31 clearances from Siemens Healthcare GmbH →