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

    FLAATZ 600 SERIES (FLAATZ 600/601)

    K Number: K132842 · Decision Feb 21, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    164

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    Basic Information

    Device Name
    FLAATZ 600 SERIES (FLAATZ 600/601)
    K Number
    K132842
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drtech Corp.
    Date Received
    September 10, 2013
    Decision Date
    February 21, 2014
    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 Drtech Corp.

    K Number Device Name
    K111655 FLAATZ 760
    K111583 FLAATZ 560
    K102474 FLAATZ 750E
    K091747 FLAATZ 500
    K080064 FLAATZ 750