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510(k) Data Aggregation

    K Number
    K140693
    Device Name
    VSCAN WITH DUAL PROBE
    Manufacturer
    GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN
    Date Cleared
    2014-05-16

    (58 days)

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

    **GE MEDICAL SYSYEMS ULTRASOUND **& PRIMARY CARE DIAGN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vscan with Dual Probe is general purpose diagnosic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e,g. Iower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, amniocentesis), Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics Its pocket-sized portability and simplified user integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during, triage assessments, and procedural guidance for adults and pediatrics.
    Device Description
    Vscan with Dual Probe is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a flip up 3.5 inch LCD display and a permanently attached dual ended (phased and linear) transducer operating B and color modes with digital acquisition, processing and display capability. The user interface control panel is composed of a navigation wheel that allows for intuitive thumb control. The battery can be charge either in the system or alone. The system contains a Docking Station, charger with cable and soft bag. Capabilities also include distance measurements, voice recordings and storage of files. Additional Vscan gateway software can be loaded on a personal computer to allow the user to review, annotate and create reports with the image, video and voice files once files are transferred using the included USB cable. Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac: Abdominal: Renal: OB/GYN: Urology: Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines. upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, thoracentesis. amniocentesis); Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics Its pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, triage assessments, and procedural guidance for adults and pediatrics.
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