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510(k) Data Aggregation

    K Number
    K973493
    Device Name
    PLANMED CYTOGUIDE
    Manufacturer
    PLANMED OY
    Date Cleared
    1997-11-10

    (56 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PLANMED CYTOGUIDE

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

    The Planmed Cytoguide is a mammography stereotactic biopsy system which is attached to Planmed Sophie Classic mammographic x-ray unit. The Cytoguide system is a removable attachment and is intended for obtaining tissue samples, for delivering localized treatment and for placement of a radio-opaque marking to assist subsequent procedures, especially for breast lesions too small to be palpable.

    Device Description

    The Planmed Cytoguide is a mammography stereotactic biopsy system which is attached to Planmed Sophie Classic mammographic x-ray unit. The Cytoguide system is a removable attachment.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) notification for the Planmed Cytoguide does not contain information on the acceptance criteria, device performance study details, or ground truth establishment. The document is primarily a notification of substantial equivalence and outlines the intended use of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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