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    K Number
    K254099

    Validate with FDA (Live)

    Device Name
    EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System
    Manufacturer
    Samsung Medison Co., Ltd.
    Date Cleared
    2026-03-27

    (98 days)

    Product Code
    IYN,ITX,IYO,LLZ
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 150
    Reference & Predicate Devices
    K252018,K250999,K233112
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K252018, K250999

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System and transducers are designed to obtain ultrasound images and analyze body fluids.

    The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Dermatology, Trans-esophageal (Cardiac) and Peripheral vessel.

    It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (including emergency rooms), private practices, clinics and similar care environment for clinical diagnosis of patients.

    Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode.

    Device Description

    EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound System are general purpose, portable (without cart)/mobile (with cart), software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, MV-Flow mode, Multi-Image mode(Dual, Quad), 3D/4D mode.

    EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound System also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals.

    EVO Q30, EVO Q20, EVO Q10, EVO XQ30, EVO XQ20, EVO XQ10, EVO QH30, EVO QH20, EVO QH10 Diagnostic Ultrasound System have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

    AI/ML Overview

    N/A

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