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510(k) Data Aggregation

    K Number
    K253310

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-11-25

    (57 days)

    Product Code
    Regulation Number
    892.1550
    Reference & Predicate Devices
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241671

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The multifunctional ultrasound scanner is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.

    Main applications

    • Cardiac
      • Districts: Cardiac Adult, Cardiac Pediatric (including newborns)
      • Invasive access: Transesophageal
    • Vascular
      • Districts: Neonatal, Adult Cephalic, Vascular
      • Invasive access: Not applicable
    • General Imaging
      • Districts: Abdominal, Musculo-skeletal, Neonatal, Pediatric, Small Organ (Testicles, Breast, Thyroid), Urologic
      • Invasive access: Intraoperative (Abdominal), Laparoscopic, Transrectal
    • Women Health
      • Districts: OB/Fetal, Gynecology
      • Invasive access: Transrectal, Transvaginal

    The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes, Elastosonography, 3D/4D and CnTI.

    The ultrasound scanner is suitable for use in health institutions and is designed for ultrasound practitioners.

    Device Description

    7600 Ultrasound System is a portable based ultrasound device used to perform diagnostic general ultrasound studies.

    7600 Ultrasound System is equipped with two LCD Color Displays. The first LCD Color Display is the main output device used to display the acquisition image, the acquisition configuration and the exam results. The second LCD is provided with Touch panel and is used as a flexible input control device because its easy configurability.

    The device uses the physical properties of the ultrasound (i.e. sound waves with frequency above 20 kHz and that are not audible to the human ear) for the visualization of deep structures of the body by recording the reflections or echoes of ultrasonic pulses directed into the tissues and of the Doppler effect, i.e. the frequency-shifted ultrasound reflections produced by moving targets (usually red blood cells) in the bloodstream, to determine both direction and velocity of blood flow in the target organs.

    The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping (TVM), Combined modes. 7600 Ultrasound System also manages Elastosonography, 3D/4D and CnTI.

    Several types of probes are used to cover different needs in terms of geometrical shape and frequency range.

    7600 Ultrasound System can drive Phased array, Convex array, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes).

    7600 Ultrasound System is equipped with wireless capability.

    7600 Ultrasound System will be available on the market in two models with the following commercial names: MyLabC25, MyLabC30.

    The difference between MyLabC25 and MyLabC30 models is only in the licenses configuration.

    7600 Ultrasound System, defined herein, is a new portable version of the cart-based 6600 Ultrasound System previously cleared under K243253.

    The proposed 7600 Ultrasound System includes a new software version that combines features FDA-cleared and already available in the predicate and reference devices (K243253 and K241671). No new functionalities have been introduced in the current software release compared to the version previously cleared.

    7600 Ultrasound System employs the same fundamental technological characteristics as its predicate device cleared via K243253.

    AI/ML Overview

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