K113034 is an FDA 510(k) clearance for the GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on December 13, 2011, 63 days after receiving the submission on October 11, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K113034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2011 |
| Decision Date | December 13, 2011 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |