FDA Product Code SAT: Pulmonary Hypertension Machine Learning-based Notification Software
Pulmonary Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Pulmonary Hypertension For Further Referral Or Diagnostic Follow-up.
Leading manufacturers include Analytics For Life, Inc. and Anumana, Inc..
FDA 510(k) Cleared Pulmonary Hypertension Machine Learning-based Notification Software Devices (Product Code SAT)
About Product Code SAT - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SAT since 2024, with 2 receiving FDA clearance (average review time: 192 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under SAT have taken an average of 242 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
SAT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →