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510(k) Data Aggregation

    K Number
    K121542
    Device Name
    PICIS WEIGHT BASED DOSE CONVERTER
    Manufacturer
    Date Cleared
    2012-08-27

    (95 days)

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

    PICIS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Picis Weight Based Dose Converter is designed for use by trained clinicians to calculate any individual patient's dose for a given agent based on a weight based determination by the clinician. Drug dosing for a patient must be made only after careful consideration of the full clinical status of the patient by the ordering clinician and the software provides no validation as to the appropriateness of the entered weight based dose. The Picis Weight Based Dose Converter is not a substitute for clinical reasoning. The Picis Weight Based Dose Converter is a convenience feature for trained clinicians based upon accurately entered data. No medical decision should be based solely upon the results provided by this software program.
    Device Description
    The Picis Weight Based Dose Converter is a drug dose conversion feature designed for use with an electronic medical record system. The feature allows a user to convert a drug dose in units per body weight to a total dose. For example, the Weight Based Dose Converter provides for a conversion of an agent dose in milligrams per kilogram of body weight to an agent dose in total milligrams according to the patient's weight.
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