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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
Regulation Description 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 4
  1.  K203192  NaviCam Xpress Stomach System
  2.  K221608  NaviCam Capsule Endoscope System with NaviCam Stom ...
  3.  K230694  NaviCam Xpress Stomach System, NaviCam Xpress Syst ...
  4.  K241934  NaviCam Xpress Stomach Capsule Endoscope System (N ...
ANX ROBOTICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

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