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

    PEDRA-17F Digital Flat Panel X-ray Detector

    K Number: K180989 · Decision Jun 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    1
    Review Days
    58

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    Basic Information

    Device Name
    PEDRA-17F Digital Flat Panel X-ray Detector
    K Number
    K180989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Radisen, Inc.
    Date Received
    April 16, 2018
    Decision Date
    June 13, 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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