NSIClass II

System, Imaging, Esophageal, Wireless, Capsule

21 CFR 876.1300 / Gastroenterology, Urology

NSI is the FDA product code for System, Imaging, Esophageal, Wireless, Capsule, a class II device type, regulated under 21 CFR 876.1300. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 7 510(k) clearances under this code, the most recent dated 2018-03-08, and no recalls.

Classification record

Product code: NSI
Device name: System, Imaging, Esophageal, Wireless, Capsule
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.
Regulation: 21 CFR 876.1300
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 7
Ingested recalls: 0

Clearances, product code NSI

By decision year

7 clearances under product code NSI with a decision year between 2004 and 2018, 2004 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code NSI by decision year
Year	Clearances
2004	2
2005	1
2006	1
2007	1
2009	1
2018	1

Applicants with the most clearances

Product code NSI

Applicants holding the most 510(k) clearances under product code NSI
Applicant	Clearances
Given Imaging Ltd.	7

Companies listing this code with FDA

Companies whose registered establishments list this code