The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Innova Solid State Xray-imager Fluoroscopic X-ray System, Models Innova 4100, 3100, 2100, 3131, 2121.
| Device ID | K091658 |
| 510k Number | K091658 |
| Device Name: | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Contact | Alan Totah |
| Correspondent | Alan Totah GE HEALTHCARE 3000 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-09 |
| Decision Date | 2009-06-29 |
| Summary: | summary |