PJA

Coronary Vascular Physiologic Simulation Software

Product code
PJA
Device name
Coronary Vascular Physiologic Simulation Software
Device class
Class 2
21 CFR
21 CFR 870.1415
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-07-18.

NumberDecision dateApplicantDevice nameSummary
K2509022025-07-18HeartFlow, Inc.HeartFlow AnalysisPDF

1 summaries are archived here for direct download.

Official FDA classification page: PJA
Classification and pathway per current FDA publications. Data from openFDA (CC0).