Device |
angiographic coronary vascular physiologic simulation software |
Regulation Description |
Coronary vascular physiologic simulation software device. |
Definition |
An angiographic coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease. |
Physical State |
Software |
Technical Method |
Performs perioperative analysis of angiographic imaging data to simulate blood flow in the coronary vasculature. |
Target Area |
Coronary Vasculature |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QEK |
Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
510(k)
|
Regulation Number |
870.1415
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |