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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radiological image processing software for ablation therapy planning and evaluation
Regulation Description Medical image management and processing system.
Definition To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
Product CodeQTZ
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
EIGEN
  SUBSTANTIALLY EQUIVALENT 1
MIM SOFTWARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
R.A.W. S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TECHSOMED
  SUBSTANTIALLY EQUIVALENT 2
TECHSOMED MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1

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