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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
2021 2 2
2022 1 1
2023 8 8
2024 14 14
2025 17 17
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 21 21
False Negative Result 21 21
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 22 22
Insufficient Information 17 17
Angina 4 4
Chest Pain 2 2
Myocardial Infarction 2 2
Cardiac Arrest 1 1
Dyspnea 1 1

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