K113758 is an FDA 510(k) clearance for the VOLUSON E6/E8/E8EXPERT/E10. This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on January 10, 2012, 20 days after receiving the submission on December 21, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K113758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2011 |
| Decision Date | January 10, 2012 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |