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
Cleared
Mar 08, 2018
PillCam Patency System
Given Imaging , Ltd.
Gastroenterology & Urology
45d
Cleared
Sep 28, 2009
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
Given Imaging , Ltd.
Gastroenterology & Urology
210d
Cleared
Jun 11, 2007
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
Given Imaging , Ltd.
Gastroenterology & Urology
47d
Cleared
May 24, 2006
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
Given Imaging , Ltd.
Gastroenterology & Urology
61d
Cleared
Dec 01, 2005
GIVEN DIAGNOSTIC SYSTEM
Given Imaging , Ltd.
Gastroenterology & Urology
112d
Cleared
Nov 24, 2004
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
Given Imaging , Ltd.
Gastroenterology & Urology
28d
Cleared
Oct 25, 2004
GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
Given Imaging , Ltd.
Gastroenterology & Urology
175d