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510(k) Data Aggregation

    K Number
    K242681
    Device Name
    NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)
    Manufacturer
    Date Cleared
    2025-02-20

    (167 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nurodata Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NUSONO Handheld Ultrasound Scanner is a portable and software-based ultrasound imaging system, indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: NUSONO-C35 Fetal, Abdominal, Pediatric, Urology, Gynecology, Lung NUSONO-L75 Pediatric, Small Organ (Thyroid, Prostate, Scrotum, Breast), Musculoskeletal (Superficial and Conventional), Peripheral Vessel, Others (Carotid), Lung NUSONO-P25 Fetal, Abdominal, Pediatric, Urology, Gynecology, Cardiac (adult and pediatric), Lung The system provides diagnostic ultrasound imaging in B mode, M mode, Color Doppler mode, Power Doppler mode and combine mode (B+M. B+CD. B+PD), intended for use in environments where healthcare is provided by trained healthcare professionals. The environments where the system can be used include physician offices, clinics, hospitals, and clinical point of care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.
    Device Description
    The NUSONO Handheld Ultrasound Scanner is a portable, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through an off-the-self (OTS) iOS 14, 15 and Android 12 or higher versions based mobile device. The system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with the NUSONO App on traditional smartphone/tablet devices via direct Wi-Fi. The NUSONO App provides the interface for mode/setting control and image display, acquisition, and storage functions. The 128-channel beamformer and image signal processing technology maximize the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system.
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