The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Centricity Pacs-iw With Universal Viewer.
| Device ID | K123174 |
| 510k Number | K123174 |
| Device Name: | CENTRICITY PACS-IW WITH 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-10 |
| Decision Date | 2012-11-16 |
| Summary: | summary |