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510(k) Data Aggregation

    K Number
    K251820
    Device Name
    ViewMateTM Ultrasound System
    Manufacturer
    Shenzhen Mindray Bio-medical Electronics Co., Ltd.
    Date Cleared
    2025-09-12

    (91 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K222754,K192410
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

    The ultrasound system is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac), and vascular); Intra-operative (Neuro); Laparoscopic; Pediatric; Small organ (thyroid, breast, testes, etc); Neonatal cephalic; Adult Cephalic/Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

    Modes of operation include: B (Includes B-Mode and Harmonic (Contrast) imaging (HI)), M, PWD (Includes PWD-Mode imaging and High Pulse Repetition Rate PWD-Mode (HPRF)), CWD, Color Doppler (Includes Color Doppler (CD), Directional Power Doppler (DPD), and Power Doppler (PD)), Combined Modes (Includes B+M, B+M+CM, M+CM, B+CD+M+CM, B+CD+PWD where CD could represent(CD, DPD, PD, or BD)), Color M-Mode (CM), 3D/4D, CEUS (Contrast agent for Liver), ARFI, 2D SWI, Freehand tissue elasticity, CEUS (Contrast agent for LVO).

    Device Description

    This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

    AI/ML Overview

    N/A

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