GIVEN DIAGNOSTIC IMAGING SYSTEM
Device Facts
| Record ID | DEN010002 |
|---|---|
| Device Name | GIVEN DIAGNOSTIC IMAGING SYSTEM |
| Applicant | Given Imaging , Ltd. |
| Product Code | NEZ · Gastroenterology, Urology |
| Decision Date | Aug 1, 2001 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 876.1300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”
