BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    3D-SHAPER

    K Number: K251022 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    2
    Review Days
    156

    Basic Information

    Device Name
    3D-SHAPER
    K Number
    K251022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3D-Shaper Medical S.L
    Date Received
    April 2, 2025
    Decision Date
    September 5, 2025
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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    Other Clearances by 3D-Shaper Medical S.L

    K Number Device Name
    K220822 3D-SHAPER