Device typeCancer risk assessment interpretive software IVD: An in vitro diagnostic interpretive software program intended to be used in the assessment of risk for developing cancer (e.g., breast, ovarian, prostate, lung, liver, gastric, pancreatic, colorectal). It uses specific algorithms to combine and correlate patient demographics, clinical observations, and the in vitro diagnostic results of the qualitative and/or quantitative detection of one or multiple cancer-specific biomarkers in a clinical specimen to establish an individual risk score that may be used to guide patient management.
FDA categoryPathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis
Device ID00850062141025
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information