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510(k) Data Aggregation

    K Number
    K203250
    Device Name
    TaiChiC
    Manufacturer
    Our United Corporation
    Date Cleared
    2021-03-12

    (128 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K193207,K200050
    Why did this record match?
    Reference Devices :

    K193207

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text describes the TaiChiC Rotating Gamma System, a teletherapy device for stereotactic radiosurgery and precision radiotherapy, and its substantial equivalence determination by the FDA. However, the document does not contain specific acceptance criteria, reported device performance metrics in a quantitative manner, detailed study designs, or information about human expert involvement for establishing ground truth.

    The performance data section broadly states:

    • Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
    • Bench Test: Conformance to various IEC standards (60601-2-11, 60601-1-3, 60601-2-68, 61217, 62274, 62366-1, 60601-1-6), RT2, ISO 15223-1, and ISO 10993-1.
    • Hardware and Software Verification and Validation Testing: Conducted according to 21 CFR §820, ISO 13485, ISO 14971, and FDA guidance for software in medical devices. The software was considered "major" level of concern.
    • Animal or clinical test: Not applicable.

    The conclusion states that verification and validation testing demonstrated that the device "met its specifications, demonstrated substantially equivalent performance to the predicate and met its intended use." One quantitative metric mentioned is "Radiologic accuracy

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