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510(k) Data Aggregation

    K Number
    K251268

    Validate with FDA (Live)

    Date Cleared
    2025-12-23

    (243 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nano Series Diagnostic Ultrasound System is intended for use by an appropriately trained and qualified healthcare professional for ultrasound evaluation in hospitals, clinics, road ambulances or at home. Nano Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Small parts, Musculoskeletal, Urology, Peripheral vascular, Pediatric, Pleural/Thoracic and Cardiac.

    The Modes of Operation for Nano Series include B mode, M mode, Doppler modes, Harmonic Imaging and their combination modes.

    Device Description

    The Nano series ultrasound diagnostic system consists of an app which can be installed on iOS or Android devices, and convex and linear transducers which use wired or wireless technology for communication.

    The Nano series diagnostic ultrasound systems transducers are available in four models: Nano C5, Nano C5 EXP, Nano L12 and Nano L12 EXP. Nano C5 and Nano C5 EXP are convex transducers, and Nano L12 and Nano L12 EXP are linear transducers.

    The system also supports various software features, including: Dual imaging, Speckle Reduction Imaging (eSRI), Auto Trace, Zoom, ECG Wave, eVocal, eWorks, Remote Diagnosis, etc.

    This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

    AI/ML Overview

    N/A

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