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510(k) Data Aggregation

    K Number
    K173395
    Device Name
    MECALL CLISIS SYSTEMS, Discovery RF180
    Manufacturer
    General Medical Merate S.P.A
    Date Cleared
    2018-05-21

    (203 days)

    Product Code
    JAA,IZI,KXJ,MQB
    Regulation Number
    892.1650
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MECALL CLISIS SYSTEMS, Discovery RF180

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

    The MECALL CLISIS SYSTEMS, Discovery RF180 is indicated for performing general radiography, fluoroscopy and angiography procedures/applications.

    The device is intended for use in:

    • Skeleton
    • Chest and lungs
    • Pediatrics
    • Emergency/traumatology
    • Gastroenterology
    • Urology and gynecology
    • Linear tomography
    • Digital angiography
    • Stitching
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for a fluoroscopic x-ray system, the MECALL CLISIS SYSTEMS, Discovery RF180. It states the indications for use but does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth, expert adjudication, or sample sizes for training or testing.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about any of the other requested study details based on this document. This document is a regulatory clearance letter, not a detailed study report.

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