# K182035: FFRct

- Pathway: 510(k) (Special)
- Applicant: HeartFlow, Inc.
- Decided: Dec 6, 2018 after 129 days
- Product code: PJA (Coronary Vascular Physiologic Simulation Software)
- Device class: 2
- Regulation: 21 CFR 870.1415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN130045 (2014). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161772: FFRct, HeartFlow, Inc. (2016) Summary page 4.

## Most influential descendants
- K190925: HeartFlow FFRct Analysis (2019), 3 descendants of its own
- K203329: HeartFlow Analysis (2021), 2 descendants of its own
- K213857: HeartFlow Analysis (2022), 1 descendant of its own
- K250902: HeartFlow Analysis (2025), 0 descendants of its own

## Indications for use
HeartFlow FFR CT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFR CT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFR CT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFR CT are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

Source page: https://510kreport.com/device/K182035
Methodology: https://510kreport.com/methodology