NSI · Class II · 21 CFR 876.1300

FDA Product Code NSI: System, Imaging, Esophageal, Wireless, Capsule

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.

Leading manufacturers include Given Imaging , Ltd..

7
Total
7
Cleared
97d
Avg days
2004
Since

FDA 510(k) Cleared System, Imaging, Esophageal, Wireless, Capsule Devices (Product Code NSI)

7 devices
1–7 of 7
Cleared Mar 08, 2018
PillCam Patency System
K180171
Given Imaging , Ltd.
Gastroenterology & Urology · 45d

About Product Code NSI - Regulatory Context