The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Centricity Universal Viewer.
| Device ID | K182419 |
| 510k Number | K182419 |
| Device Name: | Centricity Universal Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Healthcare 500 West Monroe Street Chicago, IL 60661 -3671 |
| Contact | Renee Webb |
| Correspondent | Renee Webb GE Healthcare 500 West Monroe Street Chicago, IL 60661 -3671 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-05 |
| Decision Date | 2018-12-14 |
| Summary: | summary |