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510(k) Data Aggregation

    K Number
    K092928
    Device Name
    DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
    Manufacturer
    Date Cleared
    2009-12-16

    (84 days)

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

    DIVERSILABS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DiversiLabs Dose Volume Histogram (DVH) Evaluator is intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms.
    Device Description
    The Dose Volume Histogram (DVH) Evaluator is a stand alone software application product for use on a personal computer.(PC) intended to aid with comparing radiation therapy treatment plans to applicable dose tolerance limits, and for recording followup patient response and symptoms. The DVH Evaluator is intended for use by trained medical physicists, physicians, or dosimetrists. The results must be evaluated by qualified personnel before a patient treatment. It is the responsibility of the medical physicist, physician or dosimetrist to determine whether the displayed limits and dose is adequate for a particular patient. The DVH Evaluator imports a file produced by a radiation TPS in the format of an industry standard Dicom-RT™ or vendor specific file. which contains information about a treatment. The file contains information related to the radiation dose volume for patient anatomical structures. After importing the TPS information, DVH Evaluator allows the user to select dose tolerance limits and overlay them on the dose volume information. If the dose to any contoured critical anatomical structures exceeds any of the tolerance limits, warnings are displayed on the plots. This enables clinical users to conveniently and comprehensively compare treatment plans to the user- selected dose tolerance limits. The DVH Evaluator does not control any radiation delivery devices and does not allow the export of dose limit information. The Followup Evaluator is an optional module of the DVH Evaluator which conveniently enables the user to record any response or symptoms that the patient experiences, either prior to or following treatment. This information is stored in the same database along with the DVH data for each patient for subsequent analysis. This enables convenient offline feedback to assess whether the dose tolerance limits are optimal for each clinic. The DVH Evaluator is provided to the customer on a CD or downloaded from www.DiversiLabs.com. A PC is not provided with the product. The PC requires Microsoft Windows XP or Windows Server 2003 Operating System, a minimum of 500 MHz microprocessor speed, a minimum of 256 MB RAM and 1 GB available hard drive space. Display requirements include 1024 x 768 minimum resolution with 1280 x 1024 preferred.
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