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510(k) Data Aggregation

    K Number
    K014116
    Device Name
    HAND-CARRIED ULTRASOUND SYSTEM
    Manufacturer
    SONOSITE,INC.
    Date Cleared
    2001-12-20

    (6 days)

    Product Code
    IYN
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K010374,K003399
    Predicate For
    K021628,K023957,K033367,K043452,K052109,K090059,K101757
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Laparoscopic, Intraoperative (abdominal organs and vascular), Abdominal, Small Organ (breast, thyroid, testicle), Trans-vaginal, Trans-rectal, Musculo-skeletal (conventional), Musculo-skeletal (superficial), Neonatal Cephalic, Pediatric, Cardiac (adult), Cardiac (pediatric), Peripheral Vessel.

    Device Description

    The SonoSite Hand-Carried Ultrasound System is a highly portable, softwarecontrolled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, PowerMap™ Directional Color Power Doppler, or in a combination of modes. The System has an electrocardiography (ECG) display feature and supports a 3lead ECG cable assembly to collect data. The SonoSite Hand-Carried Ultrasound System also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. The SonoSite Hand-Carried Ultrasound System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.

    AI/ML Overview

    This is a 510(k) Pre-Market Notification for a diagnostic ultrasound system, not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical studies (MRMC, standalone) in the context of AI/ML.

    The document focuses on demonstrating substantial equivalence to predicate devices for a conventional ultrasound system and its transducers, highlighting its technical characteristics, intended uses, and compliance with various medical device standards. The "performance" discussed relates to the device's ability to operate in different ultrasound modes (2D, M-Mode, Doppler) and its acoustic output limits, rather than diagnostic accuracy as evaluated for an AI algorithm.

    Therefore, it is not possible to extract the requested information regarding acceptance criteria and performance studies relevant to an AI/ML device from this document.

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