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510(k) Data Aggregation

    K Number
    K210154
    Device Name
    Labat series Diagnostic Ultrasound System
    Date Cleared
    2021-07-30

    (190 days)

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

    Shenzhen Wisonic Medical Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Labat series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small organ (breast, thyroid, testes,etc.), neonatal cephalic, adult cephalic, trans-vaginal, trans-rectal, musculo-skeletal (conventional and superficial), cardiac (adult and pediatric), trans-esoph.(cardiac), peripheral vessel and urology exams. The operator for Labat series Diagnostic Ultrasound System is intended for professional clinical staff or the qualified and trained personnel with experience in the use of ultrasound diagnostic equipment. The device is intended to be used in hospital or clinics. Modes of operation include: B-Mode, Color Mode, Power (Dirpower)-Mode, PW Doppler Mode, CW Doppler Mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging, Anatomic M and combined mode.
    Device Description
    The proposed Labat series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. The Labat series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Nine models for the main units are included in this submission, that is Labat SE, Labat SP, Labat SG, Labat PE, Labat PG, Labat TE, Labat TG, Labat IE and Labat IG. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, Holo PW, Anatomic M (AMM), Tissue Doppler Imaging (TDI) and the combined modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Labat series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG cables, gel warmer, magnetic cup, foot switch, barcode reader, laser marker. TEE( transesophageal echocardiography) architecture arm, etc. Ten different models of probes are available for the Labat series, that is C6-1B-H, C8-3-H, L15-4WB-H, L15-4NB-H, L22-10-H, L15-6-H, LH15-6-H, SP5-1-H, EV11-3-H, P7-3T-H.
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