Panels › Cardiovascular › Product code PJA · Class 2
Coronary Vascular Physiologic Simulation Software
Regulation 870.1415
1510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PJA
| Company | 510(k)s | Recalls |
|---|---|---|
| HeartFlow, Inc. | 8 | 0 |
| Elucid Bioimaging, Inc. | 1 | 0 |
| Keyamed Na, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2026 | K262015 | Elucid FFR-IQ (B.1) Elucid Bioimaging, Inc. | PJA |
| Jul 18, 2025 | K250902 | HeartFlow Analysis HeartFlow, Inc. | PJA |
| Oct 14, 2022 | K213857 | HeartFlow Analysis HeartFlow, Inc. | PJA |
| Apr 1, 2022 | K213657 | DEEPVESSEL FFR Keyamed Na, Inc. | PJA |
| Jan 8, 2021 | K203329 | HeartFlow Analysis HeartFlow, Inc. | PJA |
| Aug 15, 2019 | K190925 | HeartFlow FFRct Analysis HeartFlow, Inc. | PJA |
| Dec 6, 2018 | K182035 | FFRct HeartFlow, Inc. | PJA |
| Aug 24, 2016 | K161772 | FFRct HeartFlow, Inc. | PJA |
| Jan 13, 2016 | K152733 | FFRct HeartFlow, Inc. | PJA |
| Nov 26, 2014 | DEN130045 | HEARTFLOW FFRCT Heartflow | PJA |
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