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510(k) Data Aggregation

    K Number
    K981227
    Device Name
    SYMPHONY 360 REMOTE CONTROL TABLE
    Manufacturer
    ACOMA MEDICAL IMAGING, INC.
    Date Cleared
    1998-06-30

    (88 days)

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

    SYMPHONY 360 REMOTE CONTROL TABLE

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

    The Symphony 200 is intended to be used for routine radiography and follow-up x-rays after studies such as (e.g. gastrointestinal studies, chest, bone, arthrography, myelography, interventional, emergency, and trauma radiology).

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Symphony 9090 Remote Control Table." This document primarily addresses the FDA's determination of substantial equivalence and does not contain detailed information about acceptance criteria, device performance studies, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given input. The document is a regulatory approval letter, not a study report or technical specification detailing performance metrics.

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