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510(k) Data Aggregation

    K Number
    K210500
    Device Name
    Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
    Manufacturer
    Elekta Limited
    Date Cleared
    2021-06-11

    (109 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner. It is intended to assist a licensed medical practitioner in the defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. -Elekta Synergy and Elekta Harmony are the default entry-level configurations. They are intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated. -Elekta Infinity is the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy - SABR) in all areas of the body where such treatment is indicated. -Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia. The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.
    Device Description
    The Elekta Medical Linear Accelerator (EMLA) system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments. The Elekta Harmony being introduced with this premarket notification submission. The EMLA offers multiple treatment modalities including photon energies in the range of 4 – 25 MV and electron energies in the range of 4 – 22 MeV. Un-flattened and flattened photon energies are available. A treatment table, located in the treatment room, allows the patient to be accurately positioned to receive the prescribed radiotherapy and supports the patient during treatment. The table is capable of linear and rotational movements. The EMLA is equipped with a MV portal imaging subsystem, i.e. iViewGT, and an optional kV imaging sub-system, i.e. XVI. The user interface controlling devices are located partly in the treatment room and partly in the control room.
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    K Number
    K192482
    Device Name
    Elekta Unity
    Manufacturer
    Elekta Limited
    Date Cleared
    2019-12-05

    (86 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
    Device Description
    Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT). The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology. In addition to the MRI sequences cleared with the predicate device, the current Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment for Off-line review: - Single-shot EPI diffusion imaging (DWI) with 3 diffusion directions and up to 16 b-values. - . Diffusion imaging processing with automatic generation of the ADC and/or eADC maps.
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    K Number
    K192242
    Device Name
    Synergy Platform, Synergy, Infinity, VersaHD
    Manufacturer
    Elekta Limited
    Date Cleared
    2019-11-22

    (95 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Entry-level EMLA (Synergy Platform/Synergy) • The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner. • It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, and hypofractionation in all areas of the body where such treatment is indicated. • The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body. Mid-level EMLA (Infinity) • The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner. • It is intended to assist a licenced medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard dose fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT: stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated. • The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body. High-level EMLA (Versa HD) • The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licenced medical practitioner. • It is intended to assist a licenced practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions using standard fractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy - SBRT: stereotactic ablative radiotherapy - SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated. • The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatic with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body and for the treatment of functional disorders, such as trigeminal neuralgia.
    Device Description
    The Elekta Medical Linear Accelerator system is an image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system consists of components of the accelerator, such as, beam shaping, with imaging and accessories for patient positioning and set-up to deliver therapeutic treatments. The Elekta Medical Linear Accelerator System is currently available in the following model variants - Precise Treatment System, Elekta Synergy Platform, Elekta Synergy, Elekta Infinity and Versa HD.
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    K Number
    K182076
    Device Name
    Elekta Unity
    Manufacturer
    Elekta Limited
    Date Cleared
    2018-12-04

    (125 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment. Images provide information that may assist the therapy planning, patient positioning and treatment delivery related to radiation oncology.
    Device Description
    Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT). Elekta Unity consists of a gantry-mounted 7MV linear accelerator sub-system which rotates around a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). It is controlled by dedicated system software, which incorporates patient positioning, imaging, and treatment delivery functions, and it is designed for use in conjunction with approved compatible Oncology Information and Treatment Planning systems. The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment.
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    K Number
    K153011
    Device Name
    iViewDose R1.0
    Manufacturer
    Elekta Limited
    Date Cleared
    2015-12-11

    (58 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iViewDose is a standalone software tool, available as an optional accessory of the linear accelerator. It is intended to assist in reducing the clinical risk in the delivery of radiotherapy treatments and does not alter the treatment delivery, or impact the clinical workflow. The software is to be used for the purposes of detecting gross errors during the delivery of radiation therapy. The software acquires data using the iViewGT Electronic Portal Imaging Device at the time of treatment) and subsequently processes it. The processed data is compared with data calculated by the treatment planning system. The comparison is derived from the application of dose conversion and reconstruction algorithms to the EPID data, which is back-projected to a plane normal to a beam (2D) or multiple planes (3D) inside the patient (in vivo) or phantom (pretreatment). iViewDose is not a treatment planning system, and provides an independent means of checking the dose delivered to the patient. iViewDose therefore provides an added level of treatment assurance, thus giving clinicians greater confidence especially when complex treatment techniques are employed. iViewDose is intended to support decision making in relation to the delivery of radiation to defined target volumes performed with Elekta linear accelerators only.
    Device Description
    This Traditional 510(k) describes a new standalone software to be used with the Elekta range of medical linear accelerators, to further enhance the existing functionality. The iViewDose program uses iViewGT™ images to reconstruct the dose in 3D in the volume (patient or phantom). The program then uses a gamma analysis to compare the reconstructed dose with the TPS dose in 3D. iViewDose uses a dose reconstruction algorithm to calculate the dose in the patient from the dose delivered to the MV detector panel. The algorithm corrects for scattered radiation from the patient and the MV detector panel. You can use iViewDose in vivo to make an estimate of the delivered dose to a patient. You can also use iViewDose for pre-treatment checks to make an estimate of the delivered dose to a phantom.
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    K Number
    K131965
    Device Name
    XVI R5.0
    Manufacturer
    Elekta Limited
    Date Cleared
    2013-09-25

    (90 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of the radiation therapy treatment process for single or multiple fractions, of static and/or dynamic treatments, in gated or un-gated deliveries, in all areas of the body where such image guidance is determined by a licensed physician. It provides real-time 2D, 3D & 4D image guidance before, during and after treatment delivery, and is intended to support confirmation of patient positioning, monitoring and management of internal motion, and decision making in response to target position, size. shape and displacement resulting from organ deformation and anatomical movement in relation to surrounding critical structures. X VI facilitates precise and accurate dose placement, and patient set-up correction, through visualization of internal anatomy including target, critical structures and soft tissue with or without the use of implanted markers. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion. The Elekta digital linear accelerator can be used for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.
    Device Description
    This Traditional 510/k) describes modifications made to the XVI kilo-voltage imaging accessory of the Elekta range of digital linear accelerators. The primary reason for these modifications is to further enhance the imaging tools to support the monitoring and management of motion, by allowing visualization of tumor and surrounding critical structures during treatment delivery. Improvements have also been made to the operator interface connectivity with other systems to support distributed workflow and in the provision of licensable options to tailor individual features. The XVI system consists of a kV radiation source mounted onto the linac gantry drum and a kV radiation image detector. Incorporation of the kV imaging system onto the same structure as the treatment system allows high quality images of the patient anatomy to be acquired at the point of treatment and their content to be spatially related to the planned MV treatment, as previously cleared under Control Number (K100115) There has been no change made to the underlying technological characteristics of the product.
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    K Number
    K112613
    Device Name
    INTEGRITY(TM)
    Manufacturer
    Elekta Limited
    Date Cleared
    2011-12-16

    (100 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integrity™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated
    Device Description
    This Traditional 510(k) describes enhancements to the integral software performing the interface and machine control functions for the Elekta Limited range of medical digital linear accelerators. These modifications provide improvements to beam delivery, compatibility with a wider range of Elekta products and the provision of diagnostic tools to assist service engineers
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    K Number
    K111676
    Device Name
    APEX
    Manufacturer
    Elekta Limited
    Date Cleared
    2011-09-30

    (107 days)

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

    Elekta Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apex is an add-on microMLC system. It is an accessory to the linear accelerator used for radiation therapy and it is intended to shape the X-ray field both in static (fixed) or dynamic mode with rotating gantry as a function of the gantry angle. It is provided to assist the radiation oncologist to deliver radiation to the target tissue while sparing the surrounding normal tissues.
    Device Description
    This Traditional 510(k) describes modifications made to the add-on DMLC accessory for the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the leaf resolution - Apex 11 has a reduced leaf width of 2.5mm and increased field size. The add-on MLC Apel M consist of a 112 leaves individually controlled and monitored having a 2.5mm thickness at the isocenter and a field size of 120 mm x 140 mm.
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