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510(k) Data Aggregation

    K Number
    K991881
    Device Name
    125-IMPLANT SEEDS, MODEL STM1250
    Manufacturer
    SOURCETECH MEDICAL, L.L.C.
    Date Cleared
    2000-03-16

    (288 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. 125 mplant Seeds may be used in superficial, intraabdominal or intra-thoracic locations. 125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.

    Device Description

    Not Found

    AI/ML Overview

    This is a premarket notification for I-125 Implant Seeds, which is a medical device. The provided text is a letter from the FDA determining substantial equivalence to a predicate device and a statement of indications for use.

    Based on the provided documents, no acceptance criteria or a study proving the device meets acceptance criteria are present. The documents are a regulatory letter from the FDA and a statement of indications for use. They do not contain any performance data, study design, or acceptance criteria.

    Therefore, I cannot provide the requested information.

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