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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State The device consists of an ingestible capsule that contains a magnet, a data recorder, a portable magnetic scanner, and a magnetic controller.
Technical Method The magnetic controller is used for direct the location and view of the camera contained with an ingested capsule. The camera captures images of the gastrointestinal mucosa and transmits the images to a data recorder.
Target Area Stomach and duodenum
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeQKZ
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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