The following data is part of a premarket notification filed by Ge Healthcare Information Technologies with the FDA for Centricity Aw Suite Option.
| Device ID | K061372 |
| 510k Number | K061372 |
| Device Name: | CENTRICITY AW SUITE OPTION |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE INFORMATION TECHNOLOGIES 540 W. NW HIGHWAY Barrington, IL 60010 |
| Contact | Rhoda Valera |
| Correspondent | Elizabeth Drew UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-17 |
| Decision Date | 2006-05-30 |
| Summary: | summary |