The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Simulix-evolution With Oncentra Conebeam.
| Device ID | K052361 |
| 510k Number | K052361 |
| Device Name: | SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 -2133 |
| Contact | Lisa Dimmick |
| Correspondent | Jan Van Lochem KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-29 |
| Decision Date | 2005-10-24 |
| Summary: | summary |