About this listing
FFRct from HeartFlow, Inc appears on the U.S. FDA list of AI-enabled medical devices under submission K182035. It went through the 510(k) pathway, reviewed by the Cardiovascular panel, with an FDA decision dated December 6, 2018. Its primary FDA product code is PJA.
The FDA list records the regulatory facts above. For the device's cleared intended use, read the FDA decision summary linked at the bottom of this page.
- Device
- FFRct
- Company
- HeartFlow, Inc
- Submission number
- K182035
- Pathway
- 510(k)
- Decision date
- Dec 6, 2018
- Specialty (lead panel)
- Cardiovascular
- Primary product code
- PJA
More Cardiovascular AI devices
K260332 · Jun 8, 2026
EchoNext
Pathwai, Inc.
K252859 · May 29, 2026
ZEUS Platform (FG0501US)
iRhythm Technologies, Inc.
DEN250057 · May 22, 2026
PCWP Analysis Software
Cardiosense, Inc.
K252945 · Apr 17, 2026
Novasight Hybrid System
Conavi Medical, Inc.
K253801 · Apr 7, 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
Anumana, Inc.
K252360 · Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
Anumana, Inc.
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.