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510(k) Data Aggregation

    K Number
    K042628
    Device Name
    MODIFICATION TO: RADIANALYZER, MODEL 12711
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Date Cleared
    2005-01-19

    (114 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K022188
    Why did this record match?
    Device Name :

    MODIFICATION TO: RADIANALYZER, MODEL 12711

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

    RadiAnalyzer® is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
    RadiAnalyzer® is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.

    Device Description

    RADIAnalyzer® is a diagnostic computer designed to compute, record and display information, based on the input from PressureWire® Sensor and an Aortic Pressure Transducer (AO). The information is displayed as graphs as well as numerical values on the integrated screen and may also be transferred to a cardiac monitor, RADIAnalyzer® Printer and/or PC with external vicwing software installed such as RADIView® Software. Data includes: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Coronary Flow Reserve (CFR) and temperature.

    AI/ML Overview

    This K042628 510(k) submission for the RADIAnalyzer® Xpress does not contain the details of a study with acceptance criteria and reported device performance.

    The document is a 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for the new device.

    Therefore, I cannot provide the requested information from the provided text. The submission primarily addresses:

    • Device identification: Proprietary name, common name, classification, and predicate device.
    • Description of the device: How it functions and what it measures (systolic, diastolic, mean blood pressure, heart rate, FFR, CFR, temperature).
    • Intended Use: Diagnosis and treatment of coronary or peripheral artery disease, and its use in catheterization labs.
    • Technical Characteristics: Stating it's a smaller/lighter version of the predicate, with equivalent electrical and signal properties.
    • FDA Clearance Letter: Confirming substantial equivalence to the predicate device.
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