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510(k) Data Aggregation

    K Number
    K981678
    Device Name
    STRATA, MODEL V.O.95
    Date Cleared
    1998-12-11

    (213 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROSSES MEDICAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist. The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter). Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
    Device Description
    The proposed Strata device is a computer system developed for the use of assisting in the placement of anatomical localization and low dose rate isotope implants. This treatment planning procedure is used for lesions, benign or malignant, seated in human tissue. Strata uses multiple two dimensional images including Ultrasound and DICOM (imaging file format) images which are outlined by a qualified medical staff member, then reconstructed to create three dimensional structures and matrices. The information gathered is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
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