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

    CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105

    K Number: K853861 · Decision Oct 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    48
    Review Days
    37

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    Basic Information

    Device Name
    CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105
    K Number
    K853861
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.4010
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Canon USA, Inc.
    Date Received
    September 17, 1985
    Decision Date
    October 24, 1985
    Product Code
    IJZ
    Advisory Committee
    Pathology
    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
    IJZ Oil, Clearing

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