# K250902: HeartFlow Analysis

- Pathway: 510(k) (Traditional)
- Applicant: HeartFlow, Inc.
- Decided: Jul 18, 2025 after 114 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: 12 generations back to K913770 (1991). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213857: HeartFlow Analysis, HeartFlow, Inc. (2022) Summary page 6.
- K122429: Vessel Analysis and Autoplaque for Ors Visual, Object Research Systems (Ors), Inc. (2012) Summary page 6.

## Indications for use
The Heartflow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for adult patients (ages 22 years and older) with suspected coronary artery disease. It provides anatomic data, plaque localization and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The Heartflow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease. The Heartflow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The Heartflow Analysis is 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/K250902
Methodology: https://510kreport.com/methodology