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510(k) Data Aggregation

    K Number
    K250670
    Device Name
    EchoConfidence (USA)
    Manufacturer
    Mycardium AI Limited
    Date Cleared
    2025-06-30

    (117 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mycardium AI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report. The intended medical indication is for patients requiring review or analysis of their echocardiographic images acquired for their cardiac anatomy, structure and function. This includes automatic view classification; segmentation of cardiac structures including the left and right ventricle, chamber walls, left and right atria and great vessels; measures of cardiac function; and Doppler assessments. The intended patient population is both healthy individuals and patients in whom an underlying cardiac disease is known or suspected; the intended patient age range is for adults (>= 22 years old) and adolescent in the age range 18 – 21 years old.
    Device Description
    EchoConfidence is Software as a Medical Device (SaMD) that displays images from a Transthoracic Echocardiogram, and assists the user in reviewing the images, making measurements and writing a report.
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    K Number
    K242062
    Device Name
    1CMR Pro
    Manufacturer
    Mycardium AI Limited
    Date Cleared
    2024-11-15

    (123 days)

    Product Code
    LLZ, QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mycardium AI Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions. The intended patient population is both known healthy patients in whom an underlying cardiac disease is suspected. The standard viewing tools are indicated for all patients. The Al analysis components are not intended for use in patients with a known congenital cardiac abnormality, children (Age<18), or individuals with pacemakers (even if MRI compatible).
    Device Description
    1CMR Pro is software that displays, analyses and transfers DICOM cardiovascular images acquired in Cardiovascular Magnetic Resonance (CMR) scanners, specifically structure, function and flow in the heart and major vessels using multi-slice, multi-phase, multi-parametric and velocity encoded CMR images. It is compatible with 1.5T and 3T CMR acquisitions.
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