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510(k) Data Aggregation

    K Number
    K060895
    Device Name
    NOMOSSTAT, VERSION 1.0
    Manufacturer
    NOMOS CORP.
    Date Cleared
    2006-07-21

    (109 days)

    Product Code
    IYE,IXE
    Regulation Number
    892.5050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOMOSSTAT, VERSION 1.0

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

    The nomosSTAT device is intended to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy syment.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "nomoSTAT". It confirms that the device is substantially equivalent to a predicate device for its indicated use, which is to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy system.

    However, the letter does not contain any information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or details about the training set.

    Therefore, I cannot provide the requested information based on the given text. The provided document is a regulatory clearance letter, not a scientific study report or clinical trial summary.

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