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510(k) Data Aggregation

    K Number
    K232923
    Device Name
    Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2024-04-30

    (224 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ethos Treatment Management is indicated for use in managing and monitoring radiation therapy treatment plans and sessions. Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans.
    Device Description
    Ethos Treatment Management is a software product designed to help radiation therapy medical professionals manage treatments for patients with malignant or benign diseases for whom radiation therapy is indicated. It allows the physician to create and communicate radiation treatment intent (RT intent) to the treatment planner, review and approve candidate plans, and monitor treatment progress. It is intended to be used with a treatment planning system to treat or alleviate disease in humans by streamlining the treatment management and monitoring processes. Ethos Treatment Planning is a standalone software device designed to generate and modify radiation therapy treatment plans and manage treatment sessions. The device supports the traditional and adapted treatments, in which the scheduled plan is adapted to the patient's anatomy at the time of treatment.
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    K Number
    K232623
    Device Name
    Universal Endometrial Applicator Set (GM11009840)
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2024-04-09

    (224 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Universal Endometrial Applicator Set is indicated for use for treating cancer of the vagina, cervix, endometrium and uterus using HDR or PDR brachytherapy.
    Device Description
    The Universal Endometrial Applicator Set (GM11009840) consists of key device components and accessories made of titanium tandems and PEEK vaginal cylinder to allow for adaptation to individual anatomical situations for intracavitary brachytherapy. The Applicator is inserted into the patient and connected to an afterloader. The applicator acts to guide the radioactive source from the afterloader to the correct location or locations for treatment. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue. The key device components include: Intrauterine tandems (left angle, straight and right angle) Endometrial applicator clamping unit with grub screws & allen wrench Vaginal cylinder with lever handle Sterilization box Cleaning caps
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    K Number
    K232113
    Device Name
    Halcyon, Ethos Radiotherapy System
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2023-11-03

    (112 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Halcyon and Ethos radiotherapy system are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients. The Halcyon and Ethos Radiotherapy System produce CBCT images that can be used in Image Guided Radiation Therapy, and the simulation and planning for radiation therapy.
    Device Description
    Halcyon and Ethos radiotherapy system are single energy medical linear accelerators (linacs) designed to deliver Image Guided Radiation Therapy and radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. They consist of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room. An electron gun generates electrons which are accelerated by radio frequency (RF) power from a magnetron. The electrons strike a tungsten target producing photons (X-rays) for treatment and MV Imaging. The photons produced by the target are monitored and controlled by a pressurized ion chamber. A beam collimation subsystem consisting of a primary and secondary collimator and two stacked multileaf collimators (MLCs) shapes the photon beam to define the treatment area. X-Ray images of the patient are used by the treater to verify the correct treatment location. MV Imaging uses the treatment beam and a flat panel imager whereas kV imaging uses a high-capacity kV X-ray tube, a kV collimation system with full fan bowtie filter with movable y-blades to define the imaging beam size and to capture the image, a kV imager. Halcyon and Ethos radiotherapy system deliver a treatment generated by a Treatment Planning System from a physician's prescription. kV CBCT images from HyperSight can additionally be used for planning treatments. Ethos radiotherapy system is capable of delivering adaptive treatments which can take into account changes in tumour geometry between treatment sessions.
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    K Number
    K230576
    Device Name
    IDENTIFY
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2023-07-25

    (146 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IDENTIFY is indicated for adult patients undergoing radiotherapy treatment simulation and/or delivery. IDENTIFY is indicated for positioning of patients, and for montoring patient motion including respiratory patterns. It allows for data output to radiotherapy devices to synchronize image acquisition or treatment delivery with the acquired motion information.
    Device Description
    IDENTIFY is a system for motion monitoring during radiotherapy treatment simulation and delivery. It incorporates patient safety, quality, and workflow efficiency. Its high precision SGRT cameras support proper patient positioning and enable to monitor the patient's respiratory motion and to detect intra-fraction patient position changes during the treatment.
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    K Number
    K230699
    Device Name
    ARIA Radiation Therapy Management (v18.0)
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2023-04-10

    (28 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
    Device Description
    The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA Radiation Therapy Management supports the integration of all data and images in one central database including archiving and restoration. The different ARIA Radiation Therapy Management features support the visualization, processing, manipulation and management of all data and images stored in the system. Images can also be imported through using DICOM, the available image import filters or by means of film digitizers.
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    K Number
    K221797
    Device Name
    BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2022-09-14

    (85 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bravos Afterloader System is indicated for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy. The Transfer Guide Tubes are intended to connect between the Bravos Remote Afterloader system and its range of applicators. This connection creates a conduit for the source cable to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. The Length Assessment Device is intended to allow the user to establish an approximate length of an unknown length channel prior to the afterloader performing definitive length verification.
    Device Description
    BRAVOS Afterloader System: The BRAVOS Afterloader System is a computer controlled remote electro/mechanical system used for brachytherapy. The system automatically moves a stainless-steel cable incorporating a small, high activity Iridium-192 pellet in a steel capsule (sealed source) into applicator(s) or catheter(s) inserted into the patient close by a malignant tumor or tumor bed. Transfer Guide Tubes (TGT): Transfer Guide Tubes (TGT) are Brachytherapy applicator accessories. They are designed to provide a path for the dummy and source cable from the BRAVOS Afterloader System to the Applicator. The applicator end of a Transfer Guide Tube can vary in design to accommodate a range of Applicators. Length Assessment Device (LAD): The Length Assessment Device (LAD) is a Brachytherapy applicator accessory and is used to determine the approximate length of the inner lumen of the Transfer Guide Tubes (TGT) and applicator assembly.
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    K Number
    K210835
    Device Name
    Identify
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2021-04-20

    (29 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.
    Device Description
    Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.
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    K Number
    K190137
    Device Name
    Identify
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2019-07-10

    (162 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    IDENTIFY is indicated for patient and accessory identification, positioning and tracking for imaging and radiation therapy treatments.
    Device Description
    Identify is used for patient-setup, guidance and to monitor a patient before and during radiation treatment. The system consists of cameras, software, PC workstations, RFID kit, Interlock unit, calibration tools, Palm scan unit, RFID tags and optical markers, network components and cabling and handheld controllers.
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    K Number
    K181032
    Device Name
    Halcyon
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2018-05-09

    (21 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Halcyon is indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
    Device Description
    Halcyon is a single energy medical linac designed to deliver Image Guided Radiation Therapy and Radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
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    K Number
    K170817
    Device Name
    Halcyon
    Manufacturer
    Varian Medical Systems Inc.
    Date Cleared
    2017-06-27

    (99 days)

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

    Varian Medical Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Halcyon is indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.
    Device Description
    Halcyon is a single energy medical linac designed to deliver Image Guided Radiation Therapy and Radiosurgery, using Intensity Modulated and Volumetric Modulated Arc Therapy techniques. It consists of the accelerator and patient support within a radiation shielded treatment room and a control console outside the treatment room.
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