Angiographic Coronary Vascular Physiologic Simulation Software
Device Code: 992
Product Code(s):
QEK Definition: An Angiographic Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
Device Classification Information
| Device Type ID | 992 |
| Device Name | Angiographic Coronary Vascular Physiologic Simulation Software |
| 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 Description | Coronary Vascular Physiologic Simulation Software Device. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1415 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 992 |
| Device | Angiographic Coronary Vascular Physiologic Simulation Software |
| Product Code | QEK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Coronary Vascular Physiologic Simulation Software Device. |
| CFR Regulation Number | 870.1415 [🔎] |
TPLC Last Update: 2019-04-02 19:45:58