Zdrowie i gospodarka · 21/10/2015
FDA Classifies Coronary Vascular Physiologic Simulation Software Device into Class II with Special Controls
The FDA has classified the coronary vascular physiologic simulation software device into Class II, requiring special controls to ensure the device's safety and effectiveness, following a review process to provide reasonable assurance of its performance.
Source: Federal Register — Food and Drug AdministrationOpen original release →