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510(k) Data Aggregation

    K Number
    K041178
    Device Name
    EMPOWER TRANSFER SET, (CAT. NO. 7725)
    Manufacturer
    E-Z-EM, INC.
    Date Cleared
    2004-07-16

    (72 days)

    Product Code
    FPK
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K791131
    Why did this record match?
    Device Name :

    EMPOWER TRANSFER SET, (CAT. NO. 7725)

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

    The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

    Device Description

    The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.

    AI/ML Overview

    This document is a 510(k) summary for the E-Z-EM Empower Transfer Set, seeking clearance for a medical device. It does not contain information about studies or acceptance criteria for device performance in the way a clinical or AI performance study would.

    Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory compliance, device description, and comparison to a predicate device, not on analytical or clinical performance studies with specific acceptance criteria and detailed study designs.

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