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

    Neurophet SCALE PET

    K Number: K221405 · Decision Aug 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    Neurophet SCALE PET
    K Number
    K221405
    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
    May 16, 2022
    Decision Date
    August 5, 2022
    Product Code
    LLZ
    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
    LLZ System, Image Processing, Radiological

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    Other Clearances by Neurophet., Inc.

    K Number Device Name
    K261273 Neurophet AQUA
    K252563 Neurophet SCALE PET
    K252496 Neurophet AQUA AD Plus
    K242215 Neurophet AQUA (V3.1)
    K220437 Neurophet AQUA