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510(k) Data Aggregation

    K Number
    K243142
    Device Name
    Cranial 4Pi Immobilization
    Manufacturer
    Brainlab AG
    Date Cleared
    2025-06-23

    (266 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cranial 4Pi is intended for patient immobilization in radiotherapy and radiosurgery procedures. Cranial 4Pi is indicated for any medical condition in which the use of radiotherapy or radiosurgery may be appropriate for cranial and head & neck treatments.
    Device Description
    Cranial 4Pi is an assembly of the following medical device/ accessory groups: - CRANIAL 4PI OVERLAYS (CRANIAL 4PI CT OVERLAY, CRANIAL 4PI TREATMENT OVERLAY) - CRANIAL 4PI HEADRESTS (CRANIAL 4PI HEADREST STANDARD, CRANIAL 4PI HEADREST LOW-NECK, CRANIAL 4PI HEADREST PLATFORM) - CRANIAL 4PI HEADREST INLAYS (CRANIAL 4PI HEADREST INLAY STANDARD, CRANIAL 4PI HEADREST INLAY OPEN FACE, CRANIAL 4PI HEADREST INLAY H&N, CRANIAL 4PI HEAD SUPPORT STANDARD, CRANIAL 4PI HEAD SUPPORT WIDE) - CRANIAL 4PI MASKS (CRANIAL 4PI BASIC MASK, CRANIAL 4PI OPEN FACE MASK, CRANIAL 4PI EXTENDED MASK, CRANIAL 4PI STEREOTACTIC MASK, CRANIAL 4PI STEREOTACTIC MASK 3.2MM) - CRANIAL 4PI WEDGES AND SPACERS (CRANIAL 4PI WEDGE 5 DEG., CRANIAL 4PI WEDGE 10 DEG., CRANIAL 4PI SPACER 20MM, CRANIAL 4PI INDEXING PLATE) The Cranial 4Pi Overlays are medical devices used for fixation of the patient in a CT- resp. linear accelerator - environment. The Cranial 4Pi Headrests and the Cranial 4Pi Headrest Inlays are accessories to the Cranial 4Pi Overlays to allow an indication specific positioning of the patient's head and neck. The Cranial 4Pi Wedges and Spacers are accessories to the Cranial 4Pi Headrest Platform to adapt the inclination of the head support to the patients necks. The Cranial 4Pi Masks are accessories to the Cranial 4Pi Overlays used for producing individual custom-made masks for patient immobilization to the Cranial 4Pi Overlay.
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    K Number
    K243301
    Device Name
    MapRT
    Manufacturer
    Vision RT Ltd
    Date Cleared
    2025-05-19

    (213 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MapRT is indicated for assisting with planning of radiation therapy by: - Assessing which combinations of gantry/couch angle and isocentre may result in a collision and which are available to potentially enhance the dose distribution; and - Predicting when a treatment plan might result in a collision between the treatment machine and the patient or support structures
    Device Description
    MapRT is used by radiotherapy professionals during the CT simulation and treatment planning stages of radiotherapy for collision avoidance and facilitating dose optimisation. MapRT uses two lateral wide-field cameras in simulation to deliver a full 3D model of patients and accessories. This model is then used to calculate a clearance map for every couch (x-axis) and gantry (y-axis) angles. Radiotherapy treatment plans can then be imported automatically to check beams, arcs, and the transition clearance.
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    K Number
    K250099
    Device Name
    Mobius3D (4.1)
    Manufacturer
    Varian Medical Systems
    Date Cleared
    2025-05-16

    (122 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system, and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography). Mobius3D is not a treatment planning system. It is to be used only by trained radiation oncology personnel as a quality assurance tool.
    Device Description
    Mobius3D is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a Treatment Planning System (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software only QA tool, Mobius3D never comes into contact with patients.
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    K Number
    K250429
    Device Name
    DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
    Manufacturer
    MacroMedics BV
    Date Cleared
    2025-03-19

    (33 days)

    Product Code
    IYE, LNH
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All devices apart from Handgrips HNS, set/2 (111730): Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment. Handgrips HNS, set/2 (111730): Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
    Device Description
    The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch strips. A Coil Reference Tool accessory is available. The DSPS-Prominent baseplate supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch using couch strips. Optional accessory hand grips are available. The DSPS-Prominent cradles support the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The devices feature a cantilevered frame which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is required to be fixed to a baseplate. The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used together with a DSPS-Prominent baseplate or cradle to facilitate accurate positioning and immobilization of the head and neck or head, neck and shoulder region of the patient. The Masks which do not support the positioning of the shoulders are termed 'head only' masks. Shoulder Profile and Shim accessories are available.
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    K Number
    K241937
    Device Name
    Klarity SGRT System (ARSG-E1A, ARSG-E3A)
    Manufacturer
    Klarity Medical & Equipment (GZ) Co., Ltd.
    Date Cleared
    2025-03-18

    (259 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.
    Device Description
    Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating. With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated. With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately. With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion. Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.
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    K Number
    K242957
    Device Name
    Identify (4.0)
    Manufacturer
    Varian Medical Systems, Inc.
    Date Cleared
    2025-02-07

    (135 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    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 monitoring 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
    K240431
    Device Name
    ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
    Manufacturer
    Brainlab AG
    Date Cleared
    2024-07-24

    (161 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Device Description
    ExacTrac Dynamic (ETD) is a patient positioning and monitoring device used in a radiotherapy environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy treatment plans and the associated computed tomography (CT) data to determine the patient's planned position and compares it via oblique X-ray images to the actual patient position. The calculated correction shift will then be transferred to the treatment machine to align the patient correctly at the machine's treatment position. During treatment, the patient is monitored with a thermal-surface camera and X-ray imaging to ensure that there is no misalignment due to patient movement. Positioning and monitoring are also possible in combination with implanted markers. By defining the marker positions, ExacTrac Dynamic can position the patient by using X-rays and thereafter monitor the position during treatment. Additionally, ExacTrac Dynamic features a breath-hold (BH) functionality to serve as a tool to assist respiratory motion management. This functionality includes special features and workflows to correctly position the patient at a BH level and thereafter monitor this position using surface tracking. Regardless of the treatment indication, a correlation between the patient's surface and internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this technique is to treat the patient only during breath hold phases where the treatment target is at a certain position to reduce respiratory-induced tumor motion and to ensure a certain planned distance to OARs such as the heart. In addition to the X-ray based positioning technique, the system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has been used to position the patient). The ExacTrac Dynamic Surface (ETDS) is a camera-only platform without the X-ray system and is available as a configuration which enables surface-based patient monitoring. This system includes an identical thermal-surface camera, workstation, and interconnection hardware to the linac as the ETD system. The workflows supported by ETDS are surface based only and must be combined with an external IGRT device (e.g., CBCT).
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    K Number
    K232738
    Device Name
    BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
    Manufacturer
    PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
    Date Cleared
    2024-05-31

    (267 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeamDose is a software for the following purposes in radiotherapy: - absolute dose measurements as field class dosemeter (according to IEC 60731) - monitor calibration - positioning of detectors in PTW water phantoms The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731. The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results. Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom. The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel. The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
    Device Description
    The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values. The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms. The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters. The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor. The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
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    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?
    Product Code :

    IYE

    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
    K232489
    Device Name
    VenusX
    Manufacturer
    LinaTech LLC
    Date Cleared
    2024-04-12

    (239 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Product Code :

    IYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VenusX radiotherapy delivery system is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
    Device Description
    The VenusX Radiotherapy System is a medical linear accelerator that delivers therapeutic radiation to patient in accordance with the physician's prescription. It supports CRT /IMRT Treatment Techniques (Mode). The system consists of a photon therapeutic 6 MV X-ray radiation beam producing component with a photon diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
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