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510(k) Data Aggregation

    K Number
    K203623
    Device Name
    StentBoost Mobile
    Date Cleared
    2021-04-05

    (115 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips India Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    StentBoost Mobile is intended for use as a vascular x-ray interventional application. StentBoost Mobile provides high image quality visualization of stents in relation to vessels. StentBoost Mobile assists in the treatment of endovascular diseases by visualizing the placement and deployment of stents.
    Device Description
    StentBoost Mobile is a software product (iApp) intended to provide a high-resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.
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    K Number
    K173187
    Device Name
    MobileDiagnost M50
    Date Cleared
    2017-11-16

    (45 days)

    Product Code
    Regulation Number
    892.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips India Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MobileDiagnost M50 is a mobile radiographic system used for general X-ray imaging. This system can be used for taking x-ray images of patients who can't be moved to a fixed system. Applications include examinations of chest, upper and lower extremities, spinal column, skull radiography and abdominal cavities. MobileDiagnost M50 is not suitable for Mammography.
    Device Description
    The MobileDiagnost M50 is a digital mobile X-ray system, used to perform X-ray examinations in different locations of a hospital, particularly for the patient who cannot be transferred to a fixed X-ray room. The MobileDiagnost M50 allows the user to take X-rays on a digital wireless detector and the image can then be viewed on the Eleva Workspot. The MobileDiagnost M50 consists of a mobile base unit and a user interface combined with a flat solid state X-ray detector. It is used by the operator to generate, process and handle digital X-ray images.
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