NSI — System, Imaging, Esophageal, Wireless, Capsule Class II
Classification Details
- Product Code
- NSI
- Device Class
- Class II
- Regulation Number
- 876.1300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K180171 | given imaging | PillCam Patency System | March 8, 2018 |
| K090557 | given imaging | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATEN | September 28, 2009 |
| K071153 | given imaging | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | June 11, 2007 |
| K060805 | given imaging | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | May 24, 2006 |
| K052184 | given imaging | GIVEN DIAGNOSTIC SYSTEM | December 1, 2005 |
| K042960 | given imaging | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | November 24, 2004 |
| K041149 | given imaging | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | October 25, 2004 |