BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Neurophet SCALE PET

    K Number: K252563 · Decision May 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    217
    Registration Numbers
    217
    Same Product Code
    303
    Applicant Total
    6
    Review Days
    274

    Basic Information

    Device Name
    Neurophet SCALE PET
    K Number
    K252563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neurophet., Inc.
    Date Received
    August 14, 2025
    Decision Date
    May 15, 2026
    Product Code
    QIH
    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
    QIH Automated Radiological Image Processing Software

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    Other Clearances by Neurophet., Inc.

    K Number Device Name
    K261273 Neurophet AQUA
    K252496 Neurophet AQUA AD Plus
    K242215 Neurophet AQUA (V3.1)
    K220437 Neurophet AQUA
    K221405 Neurophet SCALE PET