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510(k) Data Aggregation

    K Number
    K112452
    Device Name
    ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
    Manufacturer
    ANGIODYNAMICS, INC.
    Date Cleared
    2012-03-30

    (218 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS

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

    AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA to AngioDynamics, Inc. regarding the clearance of their angiographic catheters. It does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The letter acknowledges a premarket notification for device modification and states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information from the provided text. The document does not describe:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for a test set or data provenance.
    • Number of experts for ground truth or their qualifications.
    • Adjudication method.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Results of a standalone (algorithm only) performance study.
    • Type of ground truth used.
    • Sample size for a training set.
    • How ground truth for a training set was established.
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