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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radiation therapy marking device
Definition A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with reusable or reprocessed needles or devices intended for diagnostic, therapeutic, or aesthetic use or to deliver other products for these uses.
Product CodeQRN
Regulation Number 892.5785
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDICAL PRECISION B.V.
  GRANTED 1
MEDICAL PRECISION BV
  SUBSTANTIALLY EQUIVALENT 1

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