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PJA — Coronary Vascular Physiologic Simulation Software Class II

FDA Device Classification

Classification Details

Product Code
PJA
Device Class
Class II
Regulation Number
870.1415
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250902heartflowHeartFlow AnalysisJuly 18, 2025
K213857heartflowHeartFlow AnalysisOctober 14, 2022
K213657keyamed naDEEPVESSEL FFRApril 1, 2022
K203329heartflowHeartFlow AnalysisJanuary 8, 2021
K190925heartflowHeartFlow FFRct AnalysisAugust 15, 2019
K182035heartflowFFRctDecember 6, 2018
K161772heartflowFFRctAugust 24, 2016
K152733heartflowFFRctJanuary 13, 2016
DEN130045heartflowHEARTFLOW FFRCTNovember 26, 2014