K250902 is an FDA 510(k) clearance for the HeartFlow Analysis. This device is classified as a Coronary Vascular Physiologic Simulation Software (Class II - Special Controls, product code PJA).
Submitted by HeartFlow, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 18, 2025, 114 days after receiving the submission on March 26, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.1415. A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease..
| 510(k) Number | K250902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2025 |
| Decision Date | July 18, 2025 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PJA - Coronary Vascular Physiologic Simulation Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1415 |
| Definition | A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease. |