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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software for visualization of vascular anatomy and intravascular devices
Regulation Description Medical image management and processing system.
Definition Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Product CodePZO
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTERYFLOW TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MENTICE SPAIN S.L.
  SUBSTANTIALLY EQUIVALENT 2
SIM&CURE
  SUBSTANTIALLY EQUIVALENT 4

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