The following data is part of a premarket notification filed by Ge Healthcare Dynamic Imaging Solutions with the FDA for Centricity Pacs Iw.
| Device ID | K082318 |
| 510k Number | K082318 |
| Device Name: | CENTRICITY PACS IW |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS 25 WALNUT ST. Monroe, CT 06468 |
| Contact | Jillian M Reed |
| Correspondent | Jillian M Reed GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS 25 WALNUT ST. Monroe, CT 06468 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-08-25 |
| Summary: | summary |