K061153 is an FDA 510(k) clearance for the GYNESONICS EC6 TRANSDUCER. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II - Special Controls, product code ITX).
Submitted by Gynesonics, Inc. (Redwood City, US). The FDA issued a Cleared decision on October 27, 2006, 184 days after receiving the submission on April 26, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.
| 510(k) Number | K061153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2006 |
| Decision Date | October 27, 2006 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | ITX - Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1570 |