The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Centricity Universal Viewer.
| Device ID | K150420 |
| 510k Number | K150420 |
| Device Name: | Centricity Universal Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 540 W NORTHWEST HIGHWAY Barrington, IL 60010 |
| Contact | Cheryl Bork |
| Correspondent | Cheryl Bork GE HEALTHCARE 540 W NORTHWEST HIGHWAY Barrington, IL 60010 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103800 | K150420 | 000 |