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

    TOP-X 650HF RADIOGRAPHIC X-RAY

    K Number: K920347 · Decision May 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    355
    Applicant Total
    9
    Review Days
    479

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    Basic Information

    Device Name
    TOP-X 650HF RADIOGRAPHIC X-RAY
    K Number
    K920347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1680
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Control-X, Inc.
    Date Received
    January 24, 1992
    Decision Date
    May 17, 1993
    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 Control-X, Inc.

    K Number Device Name
    K952265 MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
    K924445 BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY
    K920349 PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
    K920351 PCX 650HF RADIOGRAPHIC X-RAY
    K924443 RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE
    K924444 B-4 FOUR-WAY RADIOGRAPHIC TABLE
    K913577 MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
    K913578 MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR