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510(k) Data Aggregation

    K Number
    K240671
    Device Name
    XBeam (v2)
    Manufacturer
    Xstrahl Ltd.
    Date Cleared
    2024-12-04

    (268 days)

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

    Xstrahl Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation therapy. In addition, the XBeam Software can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments. XBeam is only intended to be used with Xstrahl's superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems. XBeam is intended to be used by authorized personnel trained in medical physics.
    Device Description
    XBeam is a standalone dose calculation software for Xstrahl's medical devices include: - Xstrahl 100, Xstrahl 150, Xstrahl 200, Xstrahl 300 (K962613) - X80 RADiant Photoelectric Therapy System (K172080) - . RADiant Aura (X80 RADiant Photoelectric Therapy System) (K230611) XBeam's dose calculation algorithm can be used to determine the beam-on time or monitor units based on the applicator and filter selected for the specific device. The beam-on time / monitor units are calculated based on the percent dose depth (PDD) curve and the absolute dose output for the specified applicatorfilter combination. The software allows for calculating treatment parameters for single or two (parallel opposed) beams. XBeam is intended to be used within a clinical environment where the patient is treated with Xstrahl's medical systems. XBeam is intended to be used by authorized personnel trained in medical physics. It is not intended to be used by patients or general public.
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    K Number
    K172080
    Device Name
    Photoelectric Therapy System
    Manufacturer
    Xstrahl Ltd.
    Date Cleared
    2017-09-29

    (81 days)

    Product Code
    JAD
    Regulation Number
    892.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xstrahl Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.
    Device Description
    The Photoelectric Therapy System is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. The Photoelectric Therapy System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the Photoelectric Therapy System. The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.
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