Company profile

HeartFlow, Inc.

HeartFlow, Inc. has 7 AI-enabled medical devices on the FDA list. The first decision was on January 13, 2016 and the most recent on July 18, 2025 (HeartFlow Analysis). Its most common review panel is Cardiovascular (7 devices).

7AI devices

2016First decision

2025Latest decision

1Specialties

Per year

201620182019202120222025

HeartFlow, Inc. AI devices per year: 2016 2, 2018 1, 2019 1, 2021 1, 2022 1, 2025 1

By specialty

Cardiovascular7

Related guides

Top cardiovascular devices

Timeline

July 18, 2025 · 510(k) K250902HeartFlow Analysis · Cardiovascular · PJA
October 14, 2022 · 510(k) K213857HeartFlow Analysis · Cardiovascular · PJA
January 8, 2021 · 510(k) K203329HeartFlow Analysis · Cardiovascular · PJA
August 15, 2019 · 510(k) K190925HeartFlow FFRct Analysis · Cardiovascular · PJA
December 6, 2018 · 510(k) K182035FFRct · Cardiovascular · PJA
August 24, 2016 · 510(k) K161772FFRct · Cardiovascular · PJA
January 13, 2016 · 510(k) K152733FFRct · Cardiovascular · PJA