LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K140380
    Device Name
    OPERA SWING
    Manufacturer
    GENERAL MEDICAL MERATE S.P.A.
    Date Cleared
    2014-09-26

    (224 days)

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

    OPERA SWING

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

    The Opera Swing 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 K140380 is a 510(k) clearance letter for the GENERAL MEDICAL MERATE S.P.A. "Opera Swing" device, an image-intensified fluoroscopic x-ray system.

    This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications typically associated with AI/ML device evaluations. The letter is solely an FDA clearance stating substantial equivalence to a predicate device based on the indications for use.

    Therefore, I cannot provide the requested information from this document. The sections you asked for, such as acceptance criteria, study details, sample sizes, and ground truth, are not present in this type of FDA clearance letter, which focuses on regulatory approval rather than technical performance data from a clinical study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1