NSI

7 FDA 510(k) clearances · Product code

FDA profile

Official device name

System, Imaging, Esophageal, Wireless, Capsule

Device class

Class II (moderate risk)

Regulation

21 CFR 876.1300

Medical specialty

Gastroenterology, Urology

FDA 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.

Adverse events (MAUDE)

2005: 2 · 2018: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free