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510(k) Data Aggregation

    K Number
    K981153
    Device Name
    OSIRIS
    Manufacturer
    HUESTIS MEDICAL
    Date Cleared
    1999-03-17

    (352 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUESTIS MEDICAL

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

    The OSIRIS optical outline system is used to measure patient contours for the purpose of radiotherapy treatment planning. Its main applications are for breast and abdomen treatment planning. The system utilizes existing Simulator or Therapy Room patient alignment lasers to generate visible surface anatomy shape contours.

    Device Description

    OSIRIS (Patient Verification and Contouring System)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication method, MRMC studies, standalone performance), or ground truth establishment for the OSIRIS Patient Position Verification and Contouring System.

    The document is primarily an FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its intended purpose and target users. It does not include the results of any performance studies or the criteria used to evaluate its accuracy or effectiveness.

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