Device typeClinical decision management support software IVD: An in vitro diagnostic application software program intended to facilitate clinical management decisions by receiving structured patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic, laboratory results, genomic data) and returning clinical care information (e.g., reports, pedigree diagrams, reminders, post-therapy prognosis/risk score, suggested therapy/pharmaceutical dosage) to a healthcare professional responsible for patient care. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app. It is not primarily intended to manage diagnostic/patient images.
FDA categorySoftware Device To Aid In The Prediction Or Diagnosis Of Sepsis
Device ID00860013516208
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information