PJA
9 FDA 510(k) clearances · Product code
128 daysmedian time to decision
387 days90th percentile
9clearances measured
FDA profile
- Official device name
- Coronary Vascular Physiologic Simulation Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1415
- Medical specialty
- Cardiovascular
- FDA definition
- A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
- Adverse events (MAUDE)
- 2018: 12 · 2019: 65
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HeartFlow Analysis (K250902) | HeartFlow, Inc. | 2025-07-18 |
| HeartFlow Analysis (K213857) | HeartFlow, Inc. | 2022-10-14 |
| DEEPVESSEL FFR (K213657) | Keyamed Na, Inc. | 2022-04-01 |
| HeartFlow Analysis (K203329) | HeartFlow, Inc. | 2021-01-08 |
| HeartFlow FFRct Analysis (K190925) | HeartFlow, Inc. | 2019-08-15 |
| FFRct (K182035) | HeartFlow, Inc. | 2018-12-06 |
| FFRct (K161772) | HeartFlow, Inc. | 2016-08-24 |
| FFRct (K152733) | HeartFlow, Inc. | 2016-01-13 |
| HEARTFLOW FFRCT (DEN130045) | Heartflow | 2014-11-26 |
Track PJA automatically
Every clearance here is in the API, with alerts when new ones post.