K132913 is an FDA 510(k) clearance for the VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on November 8, 2013, 52 days after receiving the submission on September 17, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K132913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2013 |
| Decision Date | November 08, 2013 |
| Days to Decision | 52 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |