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

    X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R

    K Number: K871116 · Decision May 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    56

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    Basic Information

    Device Name
    X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R
    K Number
    K871116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    X-Cel X-Ray Corp.
    Date Received
    March 19, 1987
    Decision Date
    May 14, 1987
    Product Code
    IYH
    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
    IYH Generator, Dermatological (Grenz Ray), Therapeutic X-Ray

    Other Clearances by X-Cel X-Ray Corp.

    K Number Device Name
    K993958 IDX-60 INTRAORAL X-RAY
    K930699 M6-M
    K811230 X-CELL X-RAY #'S P-75W/P-75M