Heartflow
Heartflow appears in FDA public data with 0 recalls, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jul 18, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K250902 | HeartFlow Analysis | Jul 18, 2025 |
| K213857 | HeartFlow Analysis | Oct 14, 2022 |
| K203329 | HeartFlow Analysis | Jan 8, 2021 |
| K190925 | HeartFlow FFRct Analysis | Aug 15, 2019 |
| K182035 | FFRct | Dec 6, 2018 |
| K161772 | FFRct | Aug 24, 2016 |
| K152733 | FFRct | Jan 13, 2016 |
| DEN130045 | HEARTFLOW FFRCT | Nov 26, 2014 |