The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Centricity Pacs System.
| Device ID | K043415 |
| 510k Number | K043415 |
| Device Name: | CENTRICITY PACS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 800 BUSINESS CENTER DR. Mount Prospect, IL 60056 |
| Contact | Carol Alloian |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-01-21 |
| Summary: | summary |