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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device x-ray angiographic imaging based coronary vascular simulation software device
Definition X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.
Product CodeQHA
Regulation Number 892.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERYFLOW TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIS MEDICAL IMAGING SYSTEMS BV
  SUBSTANTIALLY EQUIVALENT 1
PIE MEDICAL IMAGING B.V.
  SUBSTANTIALLY EQUIVALENT 1

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