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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastrointesinal lesion software detection system
Definition A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
Product CodeQNP
Regulation Number 876.1520
Device Class 2


Premarket Reviews
ManufacturerDecision
CHENGDU WISION MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COSMO ARTIFICIAL INTELLIGENCE - AI LTD
  SUBSTANTIALLY EQUIVALENT 3
COSMO ARTIFICIAL INTELLIGENCE - AI, LTD
  GRANTED 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ITERATIVE SCOPES INC.
  SUBSTANTIALLY EQUIVALENT 2
MAGENTIQ EYE LTD
  SUBSTANTIALLY EQUIVALENT 1

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