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510(k) Data Aggregation

    K Number
    K981672
    Device Name
    RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
    Manufacturer
    RADIOTHERAPEUTICS CORP.
    Date Cleared
    1998-07-17

    (66 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 :

    RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR

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

    The RadioTherapeutics Corp. RF Generator is a medium power electrosurgical generator intended for use with separately approved electrodes for the thermal coagulation of soft tissues.

    Device Description

    RadioTherapeutics RF-2000 Radiofrequency Generator

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance, or any studies conducted (such as standalone, MRMC, or those related to sample size, ground truth, or expert qualifications).

    The document is an FDA 510(k) clearance letter for the RadioTherapeutics RF-2000 Radiofrequency Generator, indicating that the device is substantially equivalent to a predicate device for the thermal coagulation of soft tissues. This type of letter confirms regulatory approval to market the device based on substantial equivalence, but it does not typically include detailed performance study results or acceptance criteria.

    Therefore, I cannot provide the requested table or answer the specific questions regarding studies, sample sizes, ground truth establishment, or expert involvement.

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