The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Innova Epvision 2.0, Innova Epvision 2.0.
| Device ID | K130069 |
| 510k Number | K130069 |
| Device Name: | INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Ning Wen |
| Correspondent | Ning Wen GE HEALTHCARE 283 RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-11 |
| Decision Date | 2013-04-05 |
| Summary: | summary |