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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device phase-changing fiducial marker for radiation therapy
Definition A phase-changing fiducial marker for radiation therapy is a single-use, sterile liquid material that changes phase in situ when injected in tissue for the purposes of aiding radiation therapy treatment. The device is intended to be visualized using one or more radiologic imaging modalities.
Product CodeQUV
Regulation Number 892.5727
Device Class 2


Premarket Reviews
ManufacturerDecision
NANOVI A/S
  GRANTED 1

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