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510(k) Data Aggregation

    K Number
    K190447
    Device Name
    7400 Ultrasound Systems
    Manufacturer
    Navigant Consulting - on behalf of Esaote S.p.A.
    Date Cleared
    2019-04-01

    (35 days)

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

    Navigant Consulting - on behalf of Esaote S.p.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Esaote 7400, MyLabOmega, is a compact portable system intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Laparoscopic, Pediatric, Small organs, Neonatal, Neonatal Cephalic, Adult Cephalic, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel. The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular, or other anatomical structures, as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to be connected to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
    Device Description
    The upgraded 7400 system (MyLabOmega) is portable systems equipped with a handle. The system sizes and weights allow them to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. Model 7400 manages Qualitative Elastosonography. 7400 is equipped with a LCD color display where acquired images and advanced image features are shown. 7400 can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On both models the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7400 model is equipped with wireless capability and has been designed to be powered by battery. The upgraded 7400 system, defined herein, combines the cleared features of both the 6440 and 7400 systems with new capabilities, listed below: - 1. Addition of Auto NT option. - 2. Addition of MicroV option. - 3. Addition of Qpack option. - 4. Management of probe P 1-5. - 5. Management of probe L 4-15 - 6. Addition of 4D Stic option. - 7. Addition of Full screen option. - 8. Operative system Windows 10
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