BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    TBS iNsight (V4)

    K Number: K243218 · Decision Jan 17, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    3
    Review Days
    105

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    Basic Information

    Device Name
    TBS iNsight (V4)
    K Number
    K243218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medimaps Group SA
    Date Received
    October 4, 2024
    Decision Date
    January 17, 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 Medimaps Group SA

    K Number Device Name
    K152299 TBS iNsight
    K121716 TBS INSIGHT