BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BRAINLAB MASK SYSTEM

    K Number: K945903 · Decision Jun 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    124
    Same Product Code
    717
    Applicant Total
    5
    Review Days
    185

    Basic Information

    Device Name
    BRAINLAB MASK SYSTEM
    K Number
    K945903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    BRAINLAB MED. COMPUTERSYSTEME GMBH
    Date Received
    December 2, 1994
    Decision Date
    June 5, 1995
    Product Code
    IYE
    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
    IYE Accelerator, Linear, Medical

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    Other Clearances by BRAINLAB MED. COMPUTERSYSTEME GMBH

    K Number Device Name
    K970586 BRAINLAB MICRO MULTI-LEAF COLLIMATOR
    K954861 BRAINLAB CT/X-RAY LOCALIZER
    K952390 BRAINLAB STEROTATIC HEADRING
    K934657 BRAINLAB LINAC HARDWARE