# DEN130045: Heartflow Ffrct

- Pathway: De Novo (Direct)
- Applicant: Heartflow
- Decided: Nov 26, 2014 after 387 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K152733: FFRct (2016), 9 descendants of its own
- K161772: FFRct (2016), 8 descendants of its own
- K182035: FFRct (2018), 4 descendants of its own
- K190925: HeartFlow FFRct Analysis (2019), 3 descendants of its own
- K203329: HeartFlow Analysis (2021), 2 descendants of its own

## Indications for use
HeartFlow FFRCT is a post-processing software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography (CT) DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, 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. FFRCT 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 FFRCT 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. It is for prescription use only.

Source page: https://510kreport.com/device/DEN130045
Methodology: https://510kreport.com/methodology