FDA Product Code PJA: Coronary Vascular Physiologic Simulation Software
A Coronary Vascular Physiologic Simulation Software Device Is Intended To Aid In The Identification Of Functionally Significant Cardiovascular Disease.
Leading manufacturers include HeartFlow, Inc., Heartflow and Keyamed Na, Inc..
10
Total
9
Cleared
153d
Avg days
2014
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
110d
recently vs 164d historically
FDA 510(k) Cleared Coronary Vascular Physiologic Simulation Software Devices (Product Code PJA)
10 devices
Cleared
Sep 29, 2026
Elucid FFR-IQ (B.1)
Elucid Bioimaging, Inc.
Cardiovascular
106d
Cleared
Jul 18, 2025
HeartFlow Analysis
HeartFlow, Inc.
Radiology
114d
Cleared
Oct 14, 2022
HeartFlow Analysis
HeartFlow, Inc.
Cardiovascular
308d
Cleared
Apr 01, 2022
DEEPVESSEL FFR
Keyamed Na, Inc.
Cardiovascular
133d
Cleared
Jan 08, 2021
HeartFlow Analysis
HeartFlow, Inc.
Cardiovascular
57d
Cleared
Aug 15, 2019
HeartFlow FFRct Analysis
HeartFlow, Inc.
Cardiovascular
128d
Cleared
Dec 06, 2018
FFRct
HeartFlow, Inc.
Cardiovascular
129d
Cleared
Aug 24, 2016
FFRct
HeartFlow, Inc.
Cardiovascular
57d
Cleared
Jan 13, 2016
FFRct
HeartFlow, Inc.
Cardiovascular
113d
Not Cleared
Nov 26, 2014
HEARTFLOW FFRCT
Heartflow
Cardiovascular
387d
About Product Code PJA - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code PJA since 2014, with 9 receiving FDA clearance (average review time: 153 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PJA Product Code
Recent submissions under PJA have taken an average of 110 days to reach a decision - down from 164 days historically, suggesting improved FDA processing for this classification.
PJA devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →