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Magnetically Maneuvered Capsule Endoscopy System

FDA product code QKZ · 5 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1310
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-05-04 – 2024-07-31

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.

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