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510(k) Data Aggregation

    K Number
    K231612
    Device Name
    Eve Patient Positioner System
    Manufacturer
    Leo Cancer Care
    Date Cleared
    2024-05-07

    (340 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
    Device Description
    The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments. The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.
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    K Number
    K182683
    Device Name
    Z-Robot Patient Positioning System
    Manufacturer
    Chinan Biomedical Technology, Inc.
    Date Cleared
    2019-06-27

    (274 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
    Device Description
    The Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.
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    K Number
    K170502
    Device Name
    Patient Positioning System
    Manufacturer
    Forte Automation Systems, Inc.
    Date Cleared
    2017-04-13

    (51 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient positioning system is a SCARA designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
    Device Description
    Not Found
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    K Number
    K160518
    Device Name
    LEONI ORION System
    Manufacturer
    LEONI CIA CABLE SYSTEM
    Date Cleared
    2016-07-14

    (141 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LEONI Orion System in an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
    Device Description
    The LEONI ORION System is an electro-mechanical robotic arm capable of motion in six degrees of freedom. The purpose of the device is to position a patient during radiotherapy, radiology and other medical applications with a high degree of accuracy and repeatability. The LEONI ORION System consists of the electro-mechanical unit that is a 6 axes robot which supports a standard radiotherapy table couch or other approved patient support device, and a Control Unit that includes computers and application software. The robot is linked to the Control Unit by cables.
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    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?
    Product Code :

    JAI

    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
    K122413
    Device Name
    PATIENT POSITIONING SYSTEM
    Manufacturer
    FORTE AUTOMATION SYSTEMS, INC.
    Date Cleared
    2012-09-13

    (36 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
    Device Description
    The patient positioning system is a SCARA designed robotic arm allowing six degrees of freedom.
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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?
    Product Code :

    JAI

    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.
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    K Number
    K120520
    Device Name
    EXACTRAC ROBOTICS NOVALIS ROBOTICS
    Manufacturer
    BRAINLAB AG
    Date Cleared
    2012-06-29

    (129 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K120916
    Device Name
    QFIX RADIOTHERAPY CHAIR
    Manufacturer
    WFR/AQUAPLAST CORP.
    Date Cleared
    2012-06-20

    (85 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes. It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles. The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).
    Device Description
    The Qfix Radiotherapy Chair is designed as a support and fixation device for patients undergoing radiotherapy treatment(s). Its design includes multiple adjustments on the device to accommodate patients of varying sizes. It is designed to interface with a robotic multi-axis arm by way of standard (off the shelf) robotic tooling changers. It incorporates the use of a kVue IGRT couchtop insert (K060671 The device includes a Ofix One Touch™ mechanism for kVue Couchtop Insert insertion and for the ability to use other inserts for various treatment and fixation styles. The Qfix Radiotherapy Chair will also be able to accommodate the use of the Qfix Accubite TM hite block stabilization system along with an array of WFR/Aquaplast masks (K935067) to assist in the fixation of the pationt during said treatment(s).
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    K Number
    K072898
    Device Name
    HEXAPOD EVO RT COUCH TOP
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2007-10-25

    (14 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Product Code :

    JAI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to support and aid in positioning a patient during radiation therapy.
    Device Description
    The HexaPOD evo consists of two platforms, which are connected by six length adjustable elements which are powered. By appropriate coordinative adjustment of these elements, the system is able to move the upper platform relative to the lower one. The movement can occur in all three dimensions in space. Additionally the upper platform can rotate around these three axes which results in a tilt or a rotation of the upper platform relative to the lower one. Finally an accurate positioning within all six degrees of freedom (6DOF) can be provided. The HexaPOD consists of a controller unit which is directed by a cable connected hand control. Additionally it can be directed via an external graphics user interface (GUI) which is installed on a PC.
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