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

    PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM

    K Number: K024147 · Decision Feb 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    422
    Applicant Total
    170
    Review Days
    58

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    Basic Information

    Device Name
    PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
    K Number
    K024147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Varian Medical Systems, Inc.
    Date Received
    December 16, 2002
    Decision Date
    February 12, 2003
    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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