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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, imaging, x-ray, electrostatic
Regulation Description Electrostatic x-ray imaging system.
Product CodeIXK
Regulation Number 892.1630
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA COMPANY
  SUBSTANTIALLY EQUIVALENT 2
CANON
  SUBSTANTIALLY EQUIVALENT 1
FUJI
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

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