| Device |
system, imaging, esophageal, wireless, capsule |
| Regulation Description |
Ingestible telemetric gastrointestinal capsule imaging system. |
| 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 Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | NSI |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1300
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
