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

    SII 525 APR

    K Number: K950040 · Decision Mar 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    162
    Applicant Total
    7
    Review Days
    75

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    Basic Information

    Device Name
    SII 525 APR
    K Number
    K950040
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scott Imaging Intl., Inc.
    Date Received
    January 5, 1995
    Decision Date
    March 21, 1995
    Product Code
    IZO
    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
    IZO Generator, High-Voltage, X-Ray, Diagnostic

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    Other Clearances by Scott Imaging Intl., Inc.

    K Number Device Name
    K946260 NTBS-1417, 1436, TBS-1417
    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
    K945709 SII 525 MS
    K945708 SII 360 MS