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510(k) Data Aggregation

    K Number
    K150002
    Device Name
    iNSIGHT Color Doppler Ultrasound System
    Date Cleared
    2015-06-23

    (172 days)

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

    SASET (CHENGDU) INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iNSIGHT Color DopplerUltrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
    Device Description
    The iNSIGHT Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the following imaging operations: B, M, PW, CW, CDI, PDI, DPDI, TDI, MC and THI imaging mode, Spatial Compounding Imaging, Panoramic B and Color mode, Freehand 3D, 4D Imaging, Strain imaging, ARFI Elasticity Imaging.
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    K Number
    K090059
    Device Name
    IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
    Date Cleared
    2009-04-30

    (111 days)

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

    SASET (CHENGDU) INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The iMago c21 medical ultrasound system is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets. The detailed application is listed in the User Guide-and-all these applications must be operated by qualified and trained Physician or "Sonographer".
    Device Description
    The iMago c21 Diagnostic Ultrasound System is highly mobile, software-controlled, totally digital processing and PC-based ultrasound imaging system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow(including amplitude Doppler). The system can generate real-time compound images and harmonic images, as well as 3D images and Wide-Field-of-View images. The system is designed for use in convex and linear scanning modes, and supports convex and linear array probes.
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