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510(k) Data Aggregation

    K Number
    K100079
    Device Name
    DIGITAL ULTRASOUND SCANNER
    Manufacturer
    SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD
    Date Cleared
    2010-03-01

    (48 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K081873
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    WED-3100 Digital Ultrasound Scanner is intended for diagnostic ultrasound imaging analysis for abdomen, gynecology, obstetric, urology, small-parts.
    The system is intended to use for the following type of studies: fetal, abdominal, pediatric, small organs, peripheral vascular, and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
    The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional. This device is not intended for home use.

    Device Description

    This equipment is high resolution linear/convex ultrasound scanning diagnostic equipment. It adopts micro-computer control and digital scan converter (DSC), digital beam-forming (DBF), real time dynamic aperture (RDA), real time dynamic receiving apodization, real time dynamic receiving focusing (DRF), Digital frequency scan (DFS), frame correlation technologies to endue its image with clarity, stability and high resolution.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the KLOOO79 device (WED-3100 Digital Ultrasound Scanner).

    It's important to note that this document is a 510(k) summary, which often provides a high-level overview. Detailed study protocols and results are typically found in the full 510(k) submission, which is not provided here. Therefore, some information requested might be absent or generalized.

    Acceptance Criteria and Device Performance

    The acceptance criteria for the device are generally implied by the technical specifications and the statement that "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications, including electrical safety, EMC, specifications." For specific performance criteria, we look at the 'Accuracy' and 'Resolution' values provided in the technical specifications.

    Table of Acceptance Criteria and Reported Device Performance (Implied from Technical Specifications)

    Feature/MetricAcceptance CriteriaReported Device Performance
    Accuracy (Measurements)Error ≤ ±10%Error ≤ ±10% (Stated as met)
    Resolution (C1-11 Probe)Lateral ≤1 mm (Depth≤60mm), Axial ≤1 mm (Depth≤80mm)Lateral ≤1 mm (Depth≤60mm), Axial ≤1 mm (Depth≤80mm) (Stated as met)
    Resolution (L1-5 Probe)Lateral ≤3 mm (depth≤80mm), ≤5 mm (80mm
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