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510(k) Data Aggregation

    K Number
    K190887
    Device Name
    Leksell Vantage Stereotactic System
    Manufacturer
    Elekta Instrument AB
    Date Cleared
    2019-08-01

    (119 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elekta Instrument AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
    Device Description
    The Leksell® Vantage™ Stereotactic System is a device used for minimally invasive neurosurgical procedures. It enables coordinate referencing and fixation of the patient's skull and brain during image acquisition and treatment. The coordinate referencing enables target localization and accurate stereotactic treatment of brain targets; for example for aspirations and biopsies, electrode placements, injections of cells & drugs, heamatoma evacuations as well as lesioning using a number of methodologies. The system consists of a head frame that is fixated to the patient skull by minimally invasive disposable fixation pins and a number of accessories for frame application and imaging as well as a stereotactic arc and operating room accessories for the sterile surgical procedure. The system is based on the established Leksell center-of-arc principle, which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. Compatible interventional instruments are based on the Leksell principle of an active working length of 190 mm (as the arc radius) and use the correct mechanical interfacing of the Arc instrument stop and guide holders. Various instruments, such as biopsy needles, cannulas, and electrodes can be used with the system to perform biopsies, hematoma evacuation and injections of radioactive nuclides and cytostatic agents, puncture of cysts, positioning electrodes for stimulation/ recording or lesioning and stereotactic endoscope guidance.
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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?
    Applicant Name (Manufacturer) :

    Elekta Instrument AB

    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?
    Applicant Name (Manufacturer) :

    Elekta Instrument AB

    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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    K Number
    K171123
    Device Name
    Leksell Vantage Stereotactic System
    Manufacturer
    Elekta Instrument AB
    Date Cleared
    2017-09-15

    (151 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elekta Instrument AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intended Purpose of Leksell® Vantage™ Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
    Device Description
    The Leksell® Vantage™ Stereotactic System is a device used for minimally invasive neurosurgical procedures. It enables coordinate referencing and fixation of the patient's skull and brain during image acquisition and treatment. The coordinate referencing enables target localization and accurate stereotactic treatment of brain targets; for example for aspirations and biopsies, electrode placements, injections of cells & drugs, heamatoma evacuations as well as lesioning using a number of methodologies. The system consists of a head frame that is fixated to the patient skull by minimally invasive disposable fixation pins and a number of accessories for frame application and imaging as well as a stereotactic arc and operating room accessories for the sterile surgical procedure. The system is based on the established Leksell center-of-arc principle, which allows guidance of compatible interventional instruments at any trajectory angle to the brain target. Compatible interventional instruments are based on the Leksell principle of an active working length of 190 mm (as the arc radius) and use the correct mechanical interfacing of the Arc instrument stop and guide holders. Various instruments, such as biopsy needles, cannulas, and electrodes can be used with the system to perform biopsies, hematoma evacuation and injections of radioactive nuclides and cytostatic agents, puncture of cysts, positioning electrodes for stimulation/ recording or lesioning and stereotactic endoscope guidance.
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    K Number
    K160440
    Device Name
    Leksell Gamma Knife Icon
    Manufacturer
    Elekta Instrument AB
    Date Cleared
    2016-04-20

    (63 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elekta Instrument AB

    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, 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™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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® Icon™ unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation. Each unit contains 192 sealed sources of Cobalt 60. The Leksell Gamma Knife® Icon™ system consists of several parts, physically separated into a control room and a treatment room. - The control room contains an operator console and an office cabinet. The treatment session is controlled and monitored by the operator from the control room. The control room also contains a Leksell GammaPlan computer. - The treatment room contains the Leksell Gamma Knife unit. A Leksell Gamma Knife unit consists of the radiation unit, the patient positioning system, and a set of covers. A Leksell Gamma Knife® Icon™ unit also includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system. The treatment room also contains a camera, patient speakers, a microphone, a treatment room monitor, and a radiation warning lamp. The system is electrically separated into an office side and a medical side. - The office side consists of the equipment in the control room, as well as the following equipment in the treatment room: a camera, patient speakers, a microphone, a treatment room monitor and the radiation warning lamp. The office side is powered and controlled by the office cabinet in the control room. - The medical side consists of the Leksell Gamma Knife unit in the treatment room, and is electrically isolated from the office side. The medical side is powered and controlled by a medical cabinet, placed inside the rear cover of the radiation unit.
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    K Number
    K152558
    Device Name
    Leksell Stereotactic System, Injection/ Aspiration Needle Kit
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2016-03-02

    (175 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENT AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leksell Stereotactic System is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
    Device Description
    Not Found
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    K Number
    K151159
    Device Name
    Leksell Gamma Knife Perfexion
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2015-10-29

    (181 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENT AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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, 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 of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland), and pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors).
    Device Description
    Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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 Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation. Each unit contains 192 sealed sources of Cobalt 60. Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room. - The medical side consists basically of the radiation unit with a patient positioning system. The system control and power units are placed inside the cover of the radiation unit. - The office side consists of the operator console with control panel and office computer.
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    K Number
    K151666
    Device Name
    Leksell GammaPlan
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2015-09-03

    (76 days)

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

    ELEKTA INSTRUMENT AB

    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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    K Number
    K151561
    Device Name
    Leksell Gamma Knife Icon
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2015-08-04

    (55 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENT AB

    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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, postsurgical pituitary adenomas and recurrent glioblastomas.
    Device Description
    Leksell Gamma Knife® Icon™ is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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® Icon™ unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation. Each unit contains 192 sealed sources of Cobalt 60. The Leksell Gamma Knife Icon system consists of several parts, physically separated into a control room and a treatment room. - The control room contains an operator console and an office cabinet. The . treatment session is controlled and monitored by the operator from the control room. The control room also contains a Leksell GammaPlan computer. - . The treatment room contains the Leksell Gamma Knife unit. A Leksell Gamma Knife unit consists of the radiation unit, the patient positioning system, and a set of covers. A Leksell Gamma Knife Icon unit also includes a Cone Beam CT and an Intra Fraction Motion Management (IFMM) system. The treatment room also contains a camera, patient speakers, a microphone, a treatment room monitor, and a radiation warning lamp. The system is electrically separated into an office side and a medical side. - . The office side consists of the equipment in the control room, as well as the following equipment in the treatment room: a camera, patient speakers, a microphone, a treatment room monitor and the radiation warning lamp. The office side is powered and controlled by the office cabinet in the control room. - . The medical side consists of the Leksell Gamma Knife unit in the treatment room, and is electrically isolated from the office side. The medical side is powered and controlled by a medical cabinet, placed inside the rear cover of the radiation unit.
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    K Number
    K133565
    Device Name
    LEKSELL GAMMA KNIFE PERFEXION
    Manufacturer
    ELEKTA INSTRUMENT AB
    Date Cleared
    2014-05-09

    (170 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELEKTA INSTRUMENT AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, post-surgical pituitary adenomas and recurrent glioblastomas.
    Device Description
    Leksell Gamma Knife Perfexion is a radiosurgery system for use in the stereotactic irradiation of intra-cranial 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 Perfexion unit provides highly accurate external irradiation of intra-cranial structures using collimated beams of ionizing radiation. Each unit contains 192 sealed sources of Cobalt 60. Leksell Gamma Knife Perfexion systems consists of several units, physically separated in an Office side in the control room and a Medical side in the treatment room. - The medical side consists basically of the radiation unit with a patient positioning . system. The system control and power units are placed inside the cover of the radiation unit. - The office side consists of the operator console with control panel and office computer. .
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