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510(k) Data Aggregation

    K Number
    K141486
    Device Name
    MYLABSIX ULTRASOUND SYSTEM
    Manufacturer
    ESAOTE EUROPE B.V.
    Date Cleared
    2014-07-11

    (36 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K111302,K132231,K132466,K083882
    Predicate For
    K142077,K161168
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Esaote's MyLabSix ultrasound system is a mainframe ultrasound svstem used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal Cardiac. Peripheral Vascular. Neonatal Cephalic. Adult Cephalic. Small Organs. Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

    Device Description

    The MyLabSix is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Amplitude Doppler (AD), Tissue Enhancement Imaging (TEI), XView, Multi View (MView). Trapezoidal View (TP View), Tissue Velocity Mapping (TVM), RF-based Quality Intima Media Thickness (QIMT) ,Color Flow Mapping (CFM) and Pulse Wave Doppler.

    The MyLabSix is equipped with a free orientable LCD Color Display were acquired images and advanced images are shown.

    A second LCD Display for additional controls and mode-depending keys, includes touch screen technology and is integrated in the control panel.

    The MyLabSix can drive phased (PA), convex (CA), linear array (LA) probes, Doppler probes and Volumetric probes.

    The MyLabSix is equipped with an internal Hard Disk and with an DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (Hard-Disk, PC, server) via a LAN/USB port.

    The MyLabSix is manufactured under an ISO 9001:2008 and ISO 13485:2003 certified quality system.

    AI/ML Overview

    The provided 510(k) summary for the MyLabSix Esaote Europe Ultrasound System explicitly states: "No clinical tests were performed." Therefore, there is no information in this document regarding acceptance criteria or a study proving that the device meets such criteria through clinical performance.

    The submission focuses entirely on demonstrating substantial equivalence to predicate devices (MyLabSeven and MyLabFive) and conformity to non-clinical safety and performance standards. The information provided heavily emphasizes the technological characteristics and intended uses being equivalent to already cleared devices, rather than presenting a performance study with specific acceptance criteria.

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