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510(k) Data Aggregation

    K Number
    K191491
    Device Name
    EZ-Cover
    Manufacturer
    MedXPress.Pro
    Date Cleared
    2020-06-05

    (366 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Probe cover can be used to minimize contamination between patient and ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "EZ-Cover," which is a probe cover used to minimize contamination between patient and ultrasound scanning procedures for external intact skin. This document primarily focuses on regulatory approval and does not contain specific information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details about AI/algorithm performance.

    Therefore, I cannot provide the requested information based on the input text. The text does not describe a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics, statistical analysis).

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