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510(k) Data Aggregation

    K Number
    K253597

    Validate with FDA (Live)

    Date Cleared
    2026-01-20

    (63 days)

    Product Code
    Regulation Number
    892.1550
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K182596, K232988, K212960, K252074

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

    The Diagnostic Ultrasound System Aplio beyond Model CUS-ABE00, Aplio me Model CUS-AME00 are indicated for the visualization of structures, and dynamic processes within the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and thoracic/pleural.

    This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping.

    This system is suitable for use in hospital and clinical settings by physicians or appropriately trained healthcare professionals.

    Device Description

    The Aplio beyond, Model CUS-ABE00 and Aplio me, Model CUS-AME00, V2.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 20MHz.

    AI/ML Overview

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