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

    Prudent 1717, Prudent 1417, Prudent 1212

    K Number: K211108 · Decision Jun 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    4
    Review Days
    51

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    Basic Information

    Device Name
    Prudent 1717, Prudent 1417, Prudent 1212
    K Number
    K211108
    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 14, 2021
    Decision Date
    June 4, 2021
    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
    K190691 Pixx2430 Digital Diagnostic X-Ray Receptor Panel
    K182533 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
    K180976 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels