BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Lux 35 Detector

    K Number: K203159 · Decision Dec 2, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    5
    Review Days
    40

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    Basic Information

    Device Name
    Lux 35 Detector
    K Number
    K203159
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carestream Health
    Date Received
    October 23, 2020
    Decision Date
    December 2, 2020
    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 Carestream Health

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