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510(k) Data Aggregation

    K Number
    K970586
    Device Name
    BRAINLAB MICRO MULTI-LEAF COLLIMATOR
    Manufacturer
    BRAINLAB MED. COMPUTERSYSTEME GMBH
    Date Cleared
    1997-05-12

    (87 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB MED. COMPUTERSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K954861
    Device Name
    BRAINLAB CT/X-RAY LOCALIZER
    Manufacturer
    BRAINLAB MED. COMPUTERSYSTEME GMBH
    Date Cleared
    1996-08-05

    (287 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB MED. COMPUTERSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K952390
    Device Name
    BRAINLAB STEROTATIC HEADRING
    Manufacturer
    BRAINLAB MED. COMPUTERSYSTEME GMBH
    Date Cleared
    1996-02-02

    (256 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB MED. COMPUTERSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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