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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lung 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 chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
Product CodeOEB
Regulation Number 892.2050
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2

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