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TPLC - Total Product Life Cycle
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Device gastrointestinal capsule endoscopy analysis software device
Definition A gastrointestinal capsule endoscopy analysis software device is used to analyze pre-recorded capsule endoscopy videos of the gastrointestinal tract that are suspected of containing lesions. This device uses software algorithms to identify images and areas of interest as outputs to aid the clinician in analyzing suspected lesions, for clinician review of device outputs. The device may contain hardware to support interfacing with a capsule imaging system.
Product CodeQZF
Regulation Number 876.1540
Device Class 2


Premarket Reviews
ManufacturerDecision
ANKON TECHNOLOGIES CO., LTD
  GRANTED 1

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