BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    Rho

    K Number: DEN230023 · Decision Apr 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    372

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    Basic Information

    Device Name
    Rho
    K Number
    DEN230023
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.1171
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    16 Bit, Inc.
    Date Received
    April 3, 2023
    Decision Date
    April 9, 2024
    Product Code
    SAO
    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
    SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

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