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510(k) Data Aggregation

    K Number
    K011571
    Device Name
    TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
    Manufacturer
    THE RX FILES CORP.
    Date Cleared
    2001-08-09

    (80 days)

    Product Code
    NDC
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    THE RX FILES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx1M, InterchangeRx™ and PracticePrescribeRxTM. The DoseRx™ is designed for use by trained clinicians to calculate any individual patient's optimal next dose for any given agent. The InterchangeRx™ is designed to switch a patient from one brand of agent to another while maintaining the therapeutic effect of the original agent. The PracticePrescirbeRx is a dosing simulator that offers graded prescriber training of next dose calculation scenarios with scalable patient response and surrogate marker inputs that allows the healthcare provider to gain guided and measured experience in calculating the next dose for a new or infrequently used drug. The IDS™ is not a substitute for clinical reasoning. The IDS™ is an aid for trained clinicians based upon significant and properly entered data. Final drug dose recommendations for a patient must be made only after careful consideration of the full clinical status of the patient. No medical decision should be based solely upon the results provided by this software program.
    Device Description
    The Intelligent Dosing System (IDS)™ is a three-part software suite comprised of DoseRx1M, InterchangeRx™ and PracticePrescribeRxTM.
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