K060805 is an FDA 510(k) clearance for the MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM. This device is classified as a System, Imaging, Esophageal, Wireless, Capsule (Class II - Special Controls, product code NSI).
Submitted by Given Imaging , Ltd. (Yokneam (P.O.Box 258), IL). The FDA issued a Cleared decision on May 24, 2006, 61 days after receiving the submission on March 24, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300. 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..
| 510(k) Number | K060805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2006 |
| Decision Date | May 24, 2006 |
| Days to Decision | 61 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NSI — System, Imaging, Esophageal, Wireless, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1300 |
| 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. |