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U.S. Department of Health and Human Services

Product Classification

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Device system, imaging, esophageal, wireless, capsule
Regulation Description Ingestible telemetric gastrointestinal capsule imaging system.
Definition The capsule is a disposable, ingestible capsule designed to acquire video images of the esophagus.The capsule transmits the acquired images via rf communication channel to a data recorder located outside the body.The diagnostic imaging system is intended for visualization of the esophagus rather than the small bowel.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNSI
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type 510(k)
Regulation Number 876.1300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible