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510(k) Data Aggregation

    K Number
    K242594
    Device Name
    DEEPECHO
    Manufacturer
    DeepEcho
    Date Cleared
    2025-05-23

    (266 days)

    Product Code
    IYN, IYO, QIH
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    DeepEcho

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DEEPECHO is intended to analyze fetal ultrasound images and clips using machine learning techniques to detect standard biometry views. Upon views detection, DEEPECHO assists in measurements computation of fetal biometric parameters (i.e., head circumference, abdominal circumference, femur length, and bi-parietal diameter). The device is intended for use by qualified and appropriately trained healthcare professionals as a concurrent reading and measuring aid during the acquisition and interpretation of fetal ultrasound images of patients aged 18 years or older done between the 14th and the 41st weeks of pregnancy.
    Device Description
    DEEPECHO is a cloud-based standalone software as a medical device (SaMD) that helps qualified healthcare professionals in the assessment of obstetrical images. The device is intended for use by qualified and appropriately trained healthcare professionals, including but not limited to: radiologists, obstetricians, sonographers, maternal and fetal medicine specialists, obstetricians and gynecologists, as well as fetal surgeons. The device's application is intended for pregnant patients aged 18 years and older between the 14th and the 41st weeks of pregnancy. DEEPECHO takes as an input either Digital Imaging and Communications in Medicine (DICOM) images or a live fetal ultrasound image streaming from ultrasound scanners. When DEEPECHO is in use, it allows healthcare professionals to browse fetal ultrasound images, identify views (cephalic, abdominal, and femoral) and suggest a placement for calipers on fetal ultrasound images of the identified views and compute biometrical measurements of the latter (HC (Head Circumference), BPD (Bi-parietal Diameter), FL (Femur Length), AC (Abdominal Circumference), GA (Gestational Age), EFW (Estimated Fetal Weight)). When DEEPECHO is used during real time (i.e., during the examination) the device receives real-time image streaming from an ultrasound machine and can be used to identify views (cephalic, abdominal, and femoral), and suggests a placement for calipers. These Ultrasound images are acquired using an HDMI cable that is plugged into the local device (e.g., computer, tablet) running DEEPECHO, through an HDMI to USB Video Capture. Note that the device cannot compute measurements in real time as the real time data received from the ultrasound machine is a live stream video and not in a DICOM format. DICOM data is necessary to automatically compute biometrical measurements. Additionally, DEEPECHO handles patient and exam management by allowing healthcare professionals to create, update, and archive records. When DICOM files are uploaded post-examination, the software either links the exam to an existing patient record or automatically generates a new one from the DICOM files' metadata. It enables healthcare professionals to track a patient's history, including exams, reports, and all information directly inputted to the platform.
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