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, Model: 4100iq, 3100iq, 2100iq.
| Device ID | K092004 |
| 510k Number | K092004 |
| Device Name: | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2009-08-25 |
| Summary: | summary |