Definition: A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
| Device Type ID | 965 |
| Device Name | Coronary Vascular Physiologic Simulation Software |
| Physical State | Software |
| Technical Method | Performs Offline Analysis Of Pre-existing 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1415 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 965 |
| Device | Coronary Vascular Physiologic Simulation Software |
| Product Code | PJA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Coronary Vascular Physiologic Simulation Software Device. |
| CFR Regulation Number | 870.1415 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HEARTFLOW | ||
GRANTED | 1 | |
HEARTFLOW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
False Negative Result | 24 |
| Total Device Problems | 24 |