MAUDE manufacturer profile
HEARTFLOW, INC. · PJA
MAUDE profile for Coronary Vascular Physiologic Simulation Software
Key facts
| Manufacturer | HEARTFLOW, INC. |
|---|---|
| Manufacturer group | HEARTFLOW, INC. |
| Product code | PJA |
| Product code name | Coronary Vascular Physiologic Simulation Software |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- False Negative Result, No Information, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Insufficient Information, Myocardial Infarction, Angina Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1