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510(k) Data Aggregation

    K Number
    K112539
    Device Name
    CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
    Date Cleared
    2012-01-30

    (151 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    **LEIKER REGULATORY **& QUALITY CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The system is a general-ourpose ultrasonic imstrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal.Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application: Fetal Imaging & Other, Cardiac, Peripheral Vessel Specific: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Urology, Ob/GYN, Cardiac Pediatric, Peripheral vessel
    Device Description
    The SONO TOUCH Series ultrasound system is an integrated preprogrammed ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system is configured as a portable model (SONO TOUCH Series). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems, which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, or a combination of these modes.
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