The following data is part of a premarket notification filed by Ge Medical Systems W-400 with the FDA for Seno Advantage.
| Device ID | K033400 |
| 510k Number | K033400 |
| Device Name: | SENO ADVANTAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS W-400 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger, Ph.d. |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2003-12-04 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SENO ADVANTAGE 78322110 3030243 Dead/Cancelled |
General Electric Company 2003-11-03 |