BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HyperVue™ Software

    K Number: K251198 · Decision Jul 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    45
    Applicant Total
    6
    Review Days
    90

    Basic Information

    Device Name
    HyperVue™ Software
    K Number
    K251198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrawave, Inc.
    Date Received
    April 17, 2025
    Decision Date
    July 16, 2025
    Product Code
    NQQ
    Advisory Committee
    Radiology
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NQQ System, Imaging, Optical Coherence Tomography (Oct)

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