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510(k) Data Aggregation

    K Number
    K071996
    Device Name
    MYLAB30, MODEL 7300
    Manufacturer
    ESAOTE S.P.A.
    Date Cleared
    2007-08-03

    (8 days)

    Product Code
    IYO,ITX,IYN
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040596,K052805,K060827,K033367
    Why did this record match?
    Device Name :

    MYLAB30, MODEL 7300

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

    Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. The system 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.

    Device Description

    The 7300 (MyLab30) ultrasound system is used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes. The MyLab30 system is able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the BC431 or BS230 probes, offers the possibility to also produce automatic 3D and Real Time 4D images. The 7300 (MyLab30) is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or specific studies demonstrating device performance. This document is a 510(k) summary for the MyLab30 ultrasound system, primarily focusing on its intended use, technological characteristics, and substantial equivalence to predicate devices for regulatory clearance. It does not detail specific performance metrics, clinical trials, or validation studies with acceptance criteria, sample sizes, expert ground truth adjudication, or comparative effectiveness.

    Therefore, I cannot generate the requested table and answer the associated questions based on the given information.

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