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510(k) Data Aggregation

    K Number
    K260595

    Validate with FDA (Live)

    Device Name
    Sonosite iLOOK Ultrasound System
    Manufacturer
    FUJIFILM Sonosite, Inc.
    Date Cleared
    2026-03-10

    (15 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 21
    Reference & Predicate Devices
    K250087,K180704
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sonosite iLOOK Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:

    • Pediatric
    • Peripheral vessel
    • Needle Guidance

    Modes of operation include: B Mode (B), Color Power Doppler, Color Velocity Doppler, Multi-beam imaging, and combined modes, including duplex imaging: B+C.

    This device is indicated for Prescription Use Only.

    The Sonosite iLOOK system is intended to be used in medical practices, clinical environments, including healthcare facilities, hospitals, clinics, and clinical point-of-care for diagnosis of patients. The system includes a transducer and a display connected together wirelessly. The transducer is powered by battery, while the display is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.

    Device Description

    The Sonosite iLOOK Ultrasound System is a fully featured, general-purpose, software-controlled diagnostic ultrasound system utilizing an all-digital architecture. The system is a portable ultrasound device consisting of a display, adjustment handle, wireless L15-5 linear ultrasound transducer, and a transducer holder with a built-in wireless charger.

    The system is designed to acquire and display high-resolution, real-time ultrasound data in 2D, Color Power Doppler (CPD), Color Velocity Doppler (CVD), or a combination of these modes. It provides measurement capabilities for anatomical structures and pediatric biometry, offering information for clinical diagnostic purposes.

    The system includes a variety of accessories, including an optional stand. Additionally, it features Digital Imaging and Communications in Medicine (DICOM) capabilities, along with general computer communication functionalities, including wireless networking. These capabilities enable the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops.

    The system features a single USB port, allowing the use of compatible storage devices, such as memory sticks and hard drives. An AC adapter is included in the stand module, enabling manual connection to AC power.

    AI/ML Overview

    N/A

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