LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K994016
    Device Name
    PHARMASEED, MODEL BT-103-3
    Manufacturer
    SYNCOR PHARMACEUTICALS, INC.
    Date Cleared
    2000-07-14

    (231 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

    The intended use of Syncor Pharmaceuticals' BT-103-3 seeds is to deliver radiation for brachytherapy in the treatment of cancer with sources in close proximity to, or within, the tumor. These seeds are indicated for permanent interstitial treatment of tumors which are localized and unresectable, and which have a slow growth rate and low to moderate radiosensitivity. Superficial, intrathoracic, and intraabdominal tumors, such as those in the head, neck, lungs, pancreas and prostate are commonly treated in this manner. The seeds may also be implanted in recurrent tumors or in residual tumors following completion of a course of external radiation therapy.

    Device Description

    PharmaSeed BT-103-3 Brachytherapy Seeds

    AI/ML Overview

    This PDF only contains a clearance letter for a 510(k) submission and the Indications for Use statement. It does not provide information about acceptance criteria or a study proving device performance. Therefore, I cannot fulfill your request based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1