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510(k) Data Aggregation

    K Number
    K051065
    Device Name
    RAYCELL X-RAY BLOOD IRRADIATOR
    Manufacturer
    MDS NORDION
    Date Cleared
    2005-05-26

    (30 days)

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

    RAYCELL X-RAY BLOOD IRRADIATOR

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

    The Raycell" X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease (GVHD) in accordance with applicable FDA, AABB, Health Canada, and European guidelines.

    The Raycell" X-ray Blood Irradiator is also intended for use in the irradiation of intra-operative (between three) blood for cancer patients undergoing surgery to assist in the prevention of metastasis.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes the regulatory approval of the Raycell™ X-ray Blood Irradiator and its intended uses. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot extract the information you requested. The document is a 510(k) clearance letter, which means the FDA has determined the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve the presentation of acceptance criteria or performance studies in the way you've outlined for an AI/diagnostic device.

    To directly answer your questions based only on the provided text, I would have to state that the information is not present.

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