BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    RAYCELL

    K Number: K032684 · Decision Sep 26, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    15
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    RAYCELL
    K Number
    K032684
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mds Nordion
    Date Received
    August 29, 2003
    Decision Date
    September 26, 2003
    Product Code
    MOT
    Advisory Committee
    Unknown
    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
    MOT Irradiator, Blood To Prevent Graft Versus Host Disease

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    Other Clearances by Mds Nordion

    K Number Device Name
    K060870 AVANZA
    K051065 RAYCELL X-RAY BLOOD IRRADIATOR
    K050963 GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN
    K010682 HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
    K011246 DCM 1.0
    K001006 THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE