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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUESTIS MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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)
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