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510(k) Data Aggregation

    K Number
    K163203
    Device Name
    Carestream DRX-Evolution
    Manufacturer
    Carestream Health, Inc.
    Date Cleared
    2016-12-13

    (28 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Carestream DRX-Evolution

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

    The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.

    Device Description

    permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Carestream DRX-Evolution, a stationary x-ray system. It does not contain any information regarding acceptance criteria, device performance, or any studies conducted on the device.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval and general information required for marketing the device.

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