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510(k) Data Aggregation

    K Number
    K132084
    Device Name
    PROTURA COUCH SOFTWARE
    Manufacturer
    MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
    Date Cleared
    2013-09-26

    (83 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Protura Couch Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).
    Device Description
    The proposed device, the Protura Couch Software 1.3.0 (Part No. MT6XSM1.3.0), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with record and verify systems, Linac software systems, Linac safeguard systems, and/or image guidance systems.
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    K Number
    K122201
    Device Name
    PROTURA COUCH SOFTWARE
    Manufacturer
    MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
    Date Cleared
    2012-08-30

    (36 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Protura Couch Software is interface between a record and verify system, linear accelerator (Linac) software, Linac safeguard systems, and/or image guidance systems and the Protura Couch. The Protura Couch Software is also capable of operating the Protura Couch (6 Degree Axis Couch).
    Device Description
    The proposed device, the Protura Couch Software (MT6XSMEU), is patient positioning software used in radiation treatments in conjunction with an Image Guided Radiation Therapy (IGRT) system. The Protura Couch Software interfaces with the Protura Couch Hardware (K031866) and is intended to position the patient after diagnostic decisions have been made based on results from an IGRT system. The Protura Couch Software allows the user to control patient positioning with six degrees of freedom from outside of the treatment room. The Protura Couch Software also includes the ability to interface with a record and verify system, Linac software, Linac safeguard systems, and/or image guidance systems.
    Ask a Question

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