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

    PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels

    K Number: K180976 · Decision May 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    4
    Review Days
    41

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    Basic Information

    Device Name
    PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
    K Number
    K180976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pixxgen Corporation
    Date Received
    April 13, 2018
    Decision Date
    May 24, 2018
    Product Code
    MQB
    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
    MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

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    Other Clearances by Pixxgen Corporation

    K Number Device Name
    K211108 Prudent 1717, Prudent 1417, Prudent 1212
    K190691 Pixx2430 Digital Diagnostic X-Ray Receptor Panel
    K182533 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels