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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coronary vascular physiologic simulation software
Regulation Description Coronary vascular physiologic simulation software device.
Definition A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Product CodePJA
Regulation Number 870.1415
Device Class 2


Premarket Reviews
ManufacturerDecision
HEARTFLOW, INC.
  SUBSTANTIALLY EQUIVALENT 3
KEYAMED NA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 2 2
2022 1 1
2023 8 8
2024 14 14
2025 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 29 29
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
Insufficient Information 17 17
No Information 6 6
No Consequences Or Impact To Patient 6 6
Angina 4 4
Chest Pain 2 2
Myocardial Infarction 2 2
Cardiac Arrest 1 1
Dyspnea 1 1

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