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510(k) Data Aggregation

    K Number
    K250391
    Device Name
    Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)
    Manufacturer
    Elekta Solutions AB
    Date Cleared
    2025-07-02

    (140 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K232854
    Device Name
    Leksell GammaPlan (LGP)
    Manufacturer
    Elekta Solutions AB
    Date Cleared
    2024-02-08

    (146 days)

    Product Code
    IWB, MUJ
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
    Device Description
    Leksell GammaPlan® is a powerful, computer-based treatment planning system specifically designed for the simulation and planning of stereotactic Leksell Gamma Knife® radiosurgery based on tomographic and projectional images. The basis of treatment planning is the acquisition and processing of digital images by a computer workstation running the treatment planning application software. The program is capable of handling a range of different imaging modalities. Images from tomographic sources such as Computer Tomography (CT), Magnetic Resonance (MR) and Positron Emission Tomography (PET) scanners can be used as well as projectional images from angiograms (AI). This allows the direct comparison between vascular structures in projectional images and tissue structures in CT and MR. Digital images can be imported into the system via the computer network. The treatment planning application has the ability to plan a patient's treatment protocol based on a single target or multiple targets. The basic elements of treatment planning are: - defining the cranial target or targets . - . devising the configuration of the collimators to be used during treatment - determining the parameters of the radiation shots to be delivered by Leksell • Gamma Knife®.
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    K Number
    K222047
    Device Name
    Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
    Manufacturer
    Elekta Solutions AB
    Date Cleared
    2022-10-26

    (106 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leksell Gamma Knife® is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. - · Metastatic tumors - Recurrent glioblastomas - · Trigeminal neuralgia - · Medically refractory essential tremor - · Orbital tumors - · Ocular tumors - · Optic nerve tumors · Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, chordomas, chordomas, glomus tumors, hemangiomas) - · Skull base tumors · Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, - nasopharynx, sinonasal, salivary gland) · Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, skull base tumors)
    Device Description
    Leksell Gamma Knife® (available models Icon™, Perfexion™ and Elekta Esprit) is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
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    K Number
    K203250
    Device Name
    TaiChiC
    Manufacturer
    Our United Corporation
    Date Cleared
    2021-03-12

    (128 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system is a teletherapy device intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions in the brain and head where radiation treatment is indicated.
    Device Description
    TaiChiC Rotating Gamma System has been designed to deliver radiation treatments in accordance with a prescribed plan. This system is a stereotactic radiotherapy equipment developed by applying the principle and mature technology of Cobalt-60 rotary focusing. It is suitable for brain and head lesions and tumors requiring radiotherapy, and provides image guided stereotactic radiosurgery and precision radiotherapy. TaiChiC consists of a gantry with a slip ring, a focusing gamma ray treatment head, image guidance subsystem, couch, power supply and electrical cabinet, main cover and treatment bore etc. TaiChiC combines gamma beam stereotactic radiation therapy technology with contemporary advanced image guidance technology (IGRT) to provide image guided stereiotactic radiotherapy and precision radiotherapy.
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    K Number
    K203146
    Device Name
    Akesis Galaxy RTi
    Manufacturer
    Akesis Inc
    Date Cleared
    2021-03-05

    (135 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Akesis Galaxy RTi Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures for adults.
    Device Description
    The Akesis Galaxy RTi, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. consists of a) The y-ray treatment unit, and b) interface to a stereotactic localization system, and c) kV x-ray positioning and verification system
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    K Number
    K200050
    Device Name
    Akesis Galaxy RTx
    Manufacturer
    Akesis Inc
    Date Cleared
    2020-02-04

    (25 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Akesis Galaxy RTx Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures.
    Device Description
    The Akesis Galaxy RTx, is a medical teletherapy device, which contains (30) Cobalt-60 sources, distributed in a single, compact source carrier or source drawer, which is inside a hemispheric shield. Immediately adjacent to the source unit is the "built-in" primary collimator. An independently rotating secondary collimator hemisphere contains 4 sizes of collimators and a blocking position. The rotating gamma system focuses the thirty beams and combining their individual doses at the target. The design of the system automates the treatment delivery by moving the target to the focal point, while the patient's head is immobilized in a headframe which has been fitted prior to the commencement of treatment. The entire system consists of a) the y-ray treatment unit, and b) the stereotactic localization system.
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    K Number
    K190844
    Device Name
    Akesis Galaxy
    Manufacturer
    Akesis Inc
    Date Cleared
    2019-09-04

    (156 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures
    Device Description
    The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system.
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    K Number
    K180571
    Device Name
    GammaPod
    Manufacturer
    Xcision Medical Systems, LLC
    Date Cleared
    2018-04-04

    (30 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GammaPod™ is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
    Device Description
    The GammaPod™ is a teletherapy device that uses rotating, multi-source Cobalt-60 gamma-ray emitting sources to noninvasively deliver a focal dose of radiation to a partial volume of a human breast of a patient in the prone position while sparing the surrounding normal tissues and structures. The GammaPod system contains 4 main components: i. GammaPod irradiation unit, ii. Imager loader system, iii. Breast immobilization system, and iv. Treatment planning system.
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    K Number
    K173789
    Device Name
    Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
    Manufacturer
    Elekta Instrument AB
    Date Cleared
    2018-03-30

    (106 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leksell Gamma Knife® Icon™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. • Metastatic tumors • Recurrent glioblastomas • Trigeminal neuralgia • Medically refractory essential tremor • Orbital tumors • Ocular tumors • Optic nerve tumors • Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas) • Skull base tumors • Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland) • Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors). Leksell Gamma Knife® Perfexion™ is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. • Metastatic tumors • Recurrent glioblastomas • Trigeminal neuralgia • Medically refractory essential tremor • Orbital tumors • Ocular tumors • Optic nerve tumors • Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas) • Skull base tumors • Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland) • Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
    Device Description
    Leksell Gamma Knife® Icon™ and Leksell Gamma Knife® Perfexion™ are radiosurgery systems for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target. Based on preoperative radiological examinations, the Leksell Gamma Knife unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation.
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    K Number
    K173791
    Device Name
    Leksell GammaPlan
    Manufacturer
    Elekta Instrument AB
    Date Cleared
    2018-02-09

    (57 days)

    Product Code
    IWB, MUJ
    Regulation Number
    892.5750
    Why did this record match?
    Product Code :

    IWB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leksell GammaPlan® is a computer-based system designed for Leksell Gamma Knife® treatment planning.
    Device Description
    Leksell GammaPlan® is designed for use with the Leksell Gamma Knife and is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of health care professionals (e.g. neurosurgeons, radiation therapists, radiation physicists) such that the desired radiation dose is delivered by the Leksell Gamma Knife to a precisely defined volume.
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