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510(k) Data Aggregation

    K Number
    K021934
    Device Name
    MODIFICATION TO MEDSTATION
    Manufacturer
    AISOFTW@RE MEDICAL, S.P.A.
    Date Cleared
    2002-08-12

    (61 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For radiological image display, archival, retrieval and communications

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary for the Medstation device. It primarily focuses on the regulatory approval process and does not contain information about the device's acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given text. The document confirms the substantial equivalence of the Medstation device to a legally marketed predicate device for radiological image display, archival, retrieval, and communications, but it does not detail the technical performance studies.

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