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U.S. Department of Health and Human Services

Product Classification
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Device colon capsule imaging system
Regulation Description Colon capsule endoscopy system.
Definition visualization of the colon for the detection of polyps
Physical State capsule
Technical Method The device is a single-use ingestible capsule designed to acquire video images during natural propulsion through the digestive system. It is specifically designed to visualize the complex anatomy of the colon
Target Area colon
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePGD
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 876.1330
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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