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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 Medical image management and processing 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
CORELINE SOFT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INFERVISION MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEVIS MEDICAL SOLUTIONS AG
  SUBSTANTIALLY EQUIVALENT 1
RIVERAIN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
V5MED, INC.
  SUBSTANTIALLY EQUIVALENT 1

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