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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device magnetically maneuvered capsule endoscopy system
Definition A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
Product CodeQKZ
Regulation Number 876.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
ANX ROBOTICA CORP
  SUBSTANTIALLY EQUIVALENT 2
ANX ROBOTICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
ANX ROBOTICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ANX ROBOTICA, INC.
  GRANTED 1

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