BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM

    K Number: K885327 · Decision May 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    54
    Applicant Total
    71
    Review Days
    134

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    Basic Information

    Device Name
    PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
    K Number
    K885327
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2010
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems North America, Inc.
    Date Received
    December 28, 1988
    Decision Date
    May 11, 1989
    Product Code
    LMB
    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
    LMB Device, Digital Image Storage, Radiological

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