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

    SII 525 MS

    K Number: K945709 · Decision Dec 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    7
    Review Days
    23

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    Basic Information

    Device Name
    SII 525 MS
    K Number
    K945709
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scott Imaging Intl., Inc.
    Date Received
    November 21, 1994
    Decision Date
    December 14, 1994
    Product Code
    KPR
    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
    KPR System, X-Ray, Stationary

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    Other Clearances by Scott Imaging Intl., Inc.

    K Number Device Name
    K946260 NTBS-1417, 1436, TBS-1417
    K950040 SII 525 APR
    K950041 SII 360 APR
    K946262 EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES
    K946261 MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000
    K945708 SII 360 MS