The following data is part of a premarket notification filed by Heartflow, Inc. with the FDA for Heartflow Analysis.
| Device ID | K213857 |
| 510k Number | K213857 |
| Device Name: | HeartFlow Analysis |
| Classification | Coronary Vascular Physiologic Simulation Software |
| Applicant | HeartFlow, Inc. 1400 Seaport Boulevard, Building B Redwood City, CA 94063 |
| Contact | Windi Hary |
| Correspondent | Windi Hary HeartFlow, Inc. 1400 Seaport Boulevard, Building B Redwood City, CA 94063 |
| Product Code | PJA |
| CFR Regulation Number | 870.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-10 |
| Decision Date | 2022-10-14 |