The following data is part of a premarket notification filed by Ge Healthcare Integrated It Solutions with the FDA for Centricity Pacs-iw.
| Device ID | K121387 |
| 510k Number | K121387 |
| Device Name: | CENTRICITY PACS-IW |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE INTEGRATED IT SOLUTIONS 540 W. NW HIGHWAY Barrington, IL 60010 |
| Contact | John Manarik |
| Correspondent | John Manarik GE HEALTHCARE INTEGRATED IT SOLUTIONS 540 W. NW 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 | 2012-05-08 |
| Decision Date | 2012-06-05 |
| Summary: | summary |