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

    FLAATZ 750E

    K Number: K102474 · Decision Mar 4, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    6
    Review Days
    186

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    Basic Information

    Device Name
    FLAATZ 750E
    K Number
    K102474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drtech Corp.
    Date Received
    August 30, 2010
    Decision Date
    March 4, 2011
    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
    K132842 FLAATZ 600 SERIES (FLAATZ 600/601)
    K111655 FLAATZ 760
    K111583 FLAATZ 560
    K091747 FLAATZ 500
    K080064 FLAATZ 750