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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device post-ablation tissue response prediction software
Definition A Post-ablation tissue response prediction software is an image processing device intended to aid physicians with adjunctive information in their clinical assessment of the ablation zone following a tissue ablation procedure. This device uses information extracted from medical images along with other clinical data to predict the ablation zone post treatment.
Product CodeQZL
Regulation Number 892.2052
Device Class 2


Premarket Reviews
ManufacturerDecision
TECHSOMED MEDICAL TECHNOLOGIES , LTD.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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