The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Innova Solid State Xray Imager Flurosopic X Ray System.
| Device ID | K113034 |
| 510k Number | K113034 |
| Device Name: | GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM |
| Classification | System, X-ray, Angiographic |
| Applicant | GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 |
| Contact | Carol Alloian |
| Correspondent | Carol Alloian GE HEALTHCARE 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-11 |
| Decision Date | 2011-12-13 |
| Summary: | summary |