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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
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
2019 65 65
2020 9 9
2021 2 2
2022 1 1
2023 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 84 84
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 59 59
No Consequences Or Impact To Patient 32 32
Insufficient Information 7 7
Angina 4 4
Chest Pain 3 3
Myocardial Infarction 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Dyspnea 1 1

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