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510(k) Data Aggregation

    K Number
    K242809
    Device Name
    Ascent Cardiorespiratory Diagnostic Software
    Manufacturer
    Medical Graphics Corporation
    Date Cleared
    2024-10-17

    (30 days)

    Product Code
    BTY, BZC
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical Graphics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, and cardiopulmonary testing (CPET) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency. The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
    Device Description
    Ascent™ Cardiorespiratory Diagnostic Software ("Ascent") is a stand-alone software application which can be used with several hardware devices in the Medical Graphics Corporation product line. The core purpose of the software for measurement, data collection and analysis of testing in patients who may be suffering from pulmonary illnesses like chronic obstructive pulmonary disease (COPD), asthma, exercise intolerance, heart failure and/or cardiorespiratory concerns where diagnosis and prognosis needs to be determined. In conjunction with diagnostic hardware, Ascent is used to collect data pertaining to the patient's degree of obstruction, lung volumes, and diffusing capacity. It is also used to present the collected lung diagnostic information so that it can be checked for quality and interpreted by a qualified physician, often a pulmonologist or cardiologist. All the measurements are performed via a mouthpiece or a face mask.
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    K Number
    K181912
    Device Name
    Ascent Cardiorespiratory Diagnostic Software
    Manufacturer
    Medical Graphics Corporation
    Date Cleared
    2019-04-12

    (269 days)

    Product Code
    BTY
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical Graphics Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The test can be viewed on-line with the help of a computer screen and can be printed after the test results can be saved for further referral or report generation purposes. For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency. The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.
    Device Description
    In conjunction with pulmonary diagnostic hardware, Ascent software, a Windows desktop application developed using Microsoft's NET Framework, is used to collect data pertaining to the patient's degree of obstruction, lung volumes, and diffusing capacity. It is also used to present the collected lung diagnostic information so that it can be checked for quality and interpreted by a qualified physician, usually a pulmonologist. The core purpose of the software is to facilitate pulmonary function testing in patients who may be suffering from pulmonary illnesses like Chronic Obstructive Pulmonary Disease and asthma. The software will interact with connected Medical Graphics Corporation diagnostic devices to perform the desired pulmonary function tests on the patient by a professional pulmonary function technologist. The application will display both actual and derived test variables to the user after a test is performed for purposes of data review.
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