Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list HeartFlow, Inc. with 7 510(k) clearances and 7 AI-enabled devices. The most recent is a 510(k) clearance dated Jul 18, 2025: HeartFlow Analysis.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 18, 2025 | HeartFlow AnalysisK250902 · PJA | 510(k) clearances |
| Jul 18, 2025 | HeartFlow AnalysisK250902 · Cardiovascular | AI-enabled devices |
| Oct 14, 2022 | HeartFlow AnalysisK213857 · PJA | 510(k) clearances |
| Oct 14, 2022 | HeartFlow AnalysisK213857 · Cardiovascular | AI-enabled devices |
| Jan 8, 2021 | HeartFlow AnalysisK203329 · PJA | 510(k) clearances |
| Jan 8, 2021 | HeartFlow AnalysisK203329 · Cardiovascular | AI-enabled devices |
| Aug 15, 2019 | HeartFlow FFRct AnalysisK190925 · PJA | 510(k) clearances |
| Aug 15, 2019 | HeartFlow FFRct AnalysisK190925 · Cardiovascular | AI-enabled devices |
| Dec 6, 2018 | FFRctK182035 · PJA | 510(k) clearances |
| Dec 6, 2018 | FFRctK182035 · Cardiovascular | AI-enabled devices |
| Aug 24, 2016 | FFRctK161772 · PJA | 510(k) clearances |
| Aug 24, 2016 | FFRctK161772 · Cardiovascular | AI-enabled devices |
| Jan 13, 2016 | FFRctK152733 · PJA | 510(k) clearances |
| Jan 13, 2016 | FFRctK152733 · Cardiovascular | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
