AI devices with FDA product code PJA — Coronary Vascular Physiologic Simulation Software
Product code PJA (“Coronary Vascular Physiologic Simulation Software” in openFDA) covers 8 devices on the FDA AI-enabled list, from 4 companies. Most are reviewed by the Cardiovascular panel (8). The most recent decision was HeartFlow Analysis on July 18, 2025.
8AI devices
2Companies
2016First decision
2025-07-18Latest decision
Trend: devices per year
201620182019202120222025
Top companies
All 8 devices, newest first
- HeartFlow AnalysisHeartFlow, Inc. · Cardiovascular
- HeartFlow AnalysisHeartFlow, Inc. · Cardiovascular
- DEEPVESSEL FFRKeyaMed NA Inc. · Cardiovascular
- HeartFlow AnalysisHeartFlow, Inc. · Cardiovascular
- HeartFlow FFRct AnalysisHeartFlow, Inc. · Cardiovascular
- FFRctHeartFlow, Inc · Cardiovascular
- FFRctHEARTFLOW, INC. · Cardiovascular
- FFRctHEARTFLOW, INC. · Cardiovascular