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510(k) Data Aggregation

    K Number
    K963302
    Date Cleared
    1997-02-06

    (168 days)

    Product Code
    Regulation Number
    892.1570
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Tayman Medical, Inc. Stepping and Stabilization System is used to provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer.

    Device Description

    The seeding device is comprised of three basic components. The adjustable height base. The adjustable, multi-axis head. The ultrasound probe holder and needle guide.

    AI/ML Overview

    The provided text is a summary of safety and effectiveness for a medical device (Tayman Medical, Inc. Stepping and Stabilization System). It describes the device, its intended use, and its similarities to a predicate device.

    However, the document does not contain any information regarding acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in the prompt.

    Therefore, I cannot fulfill the request using the provided input. The document focuses on regulatory equivalence rather than performance evaluation against specific criteria.

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