The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Oncentra Simulation 2.3.
| Device ID | K090706 |
| 510k Number | K090706 |
| Device Name: | ONCENTRA SIMULATION 2.3 |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 |
| Contact | Elaine Colby |
| Correspondent | Elaine Colby NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia, MD 21046 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-17 |
| Decision Date | 2009-06-15 |
| Summary: | summary |