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510(k) Data Aggregation

    K Number
    K982854
    Device Name
    MR COMPATIBLE LEVEEN NEEDLE ELECTRODE
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1998-11-10

    (89 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MR COMPATIBLE LEVEEN NEEDLE ELECTRODE

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

    The MR Compatible LeVeen Needle Electrode is intended to be used in conjunction with separately approved RF Generators such as the RadioTherapeutics RF-2000, for the thermal coagulation necrosis of soft tissues.

    Device Description

    MR Compatible LeVeen Needle Electrode

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device (MR Compatible LeVeen Needle Electrode). It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and allows the manufacturer to market the device.

    Therefore, I cannot provide the requested information. This document does not describe:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes or data provenance for a test set.
    • Number or qualifications of experts for ground truth establishment.
    • Adjudication method.
    • Multi-reader multi-case comparative effectiveness study results.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.
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