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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cabinet, emission computed tomography system
Definition Obtain Emission Computed Tomography (PET, SPECT or Gamma Camera) with or without x-ray (e.g., CT) imaging of harvested specimens from various anatomical regions in order to provide verification that the correct tissue has been excised during surgical procedures
Product CodeQXL
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
XEOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

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