The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Innova Vision, Model S18751vn, Innova Trackvision, Model S18751vt, Innova Epvision, Model S18751ep.
| Device ID | K092639 |
| 510k Number | K092639 |
| Device Name: | INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW BLVD W450 Waukesha, WI 53188 |
| Contact | Nicole Landreville |
| Correspondent | Nicole Landreville GE MEDICAL SYSTEMS SCS 3000 NORTH GRANDVIEW BLVD W450 Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-27 |
| Decision Date | 2009-12-02 |
| Summary: | summary |