The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Advantage Workstation 4.3..
| Device ID | K052995 |
| 510k Number | K052995 |
| Device Name: | ADVANTAGE WORKSTATION 4.3. |
| Classification | System, Image Processing, Radiological |
| Applicant | GE HEALTHCARE 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-25 |
| Decision Date | 2005-11-08 |
| Summary: | summary |