The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Advantage Sim Md.
| Device ID | K052345 |
| 510k Number | K052345 |
| Device Name: | ADVANTAGE SIM MD |
| Classification | System, Simulation, Radiation Therapy |
| 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 | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-26 |
| Decision Date | 2005-09-14 |
| Summary: | summary |