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510(k) Data Aggregation
K Number
K121542Device Name
PICIS WEIGHT BASED DOSE CONVERTER
Manufacturer
Date Cleared
2012-08-27
(95 days)
Product Code
Regulation Number
868.1890Why 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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