The following data is part of a premarket notification filed by General Electric Medical Systems with the FDA for Advantage Sim 6.0.
| Device ID | K021780 |
| 510k Number | K021780 |
| Device Name: | ADVANTAGE SIM 6.0 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | GENERAL ELECTRIC MEDICAL SYSTEMS 3000 NORTH GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Larry A Kroger |
| Correspondent | Wolfram Gmelin TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-05-30 |
| Decision Date | 2002-07-29 |
| Summary: | summary |