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510(k) Data Aggregation

    K Number
    K010065
    Device Name
    CRANIAL STEREOTACTIC EQUIPMENT
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2002-07-02

    (540 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K004023
    Device Name
    INTRA OPERATIVE RADIATION THERAPY
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-09-21

    (268 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003779
    Device Name
    IMMOBILIZATION SYSTEM FOR ENT
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-07-12

    (217 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K003778
    Device Name
    BREAST-BOARD (MULTIPLE)
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-06-08

    (183 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010172
    Device Name
    LEAD BLOCKS
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-04-18

    (90 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010174
    Device Name
    TRAY ADAPTERS, MULTIPLE
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-04-18

    (90 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010063
    Device Name
    COUCH FOR TOTAL BODY RADIATION
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-04-02

    (84 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K004015
    Device Name
    BEAM BLOCK TRAYS
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-03-13

    (76 days)

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

    ARPLAY MEDICAL S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010062
    Device Name
    STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
    Manufacturer
    ARPLAY MEDICAL S.A.
    Date Cleared
    2001-03-13

    (64 days)

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

    ARPLAY MEDICAL S.A.

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

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