The following data is part of a premarket notification filed by Ge Oec Medical Systems with the FDA for 9900 Plus Mobile Fluoroscopy System With 3d And Navigation Options.
| Device ID | K061953 |
| 510k Number | K061953 |
| Device Name: | 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Contact | Greg Hansen |
| Correspondent | Greg Hansen GE OEC MEDICAL SYSTEMS 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-10 |
| Decision Date | 2006-08-15 |
| Summary: | summary |