Device |
interventional cardiovascular implant simulation software device |
Regulation Description |
Interventional cardiovascular implant simulation software device. |
Definition |
An interventional cardiovascular implant simulation software device is a prescription device that provides a computer simulation of an interventional cardiovascular implant device inside a patient’s cardiovascular anatomy. It performs computational modeling to predict the interaction of the interventional cardiovascular implant device with the patient-specific anatomical environment. |
Product Code | QQI |
Regulation Number |
870.1405
|
Device Class |
2
|