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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device colon computed tomography system, computer aided detection
Regulation Description Picture archiving and communications system.
Definition To assist radiologists in the review of multi-slice computed tomography (msct) exams of the colon and highlight potential polyps that the radiologist should review.
Product CodeNWE
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

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