The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Ximatron Iv.
| Device ID | K781496 |
| 510k Number | K781496 |
| Device Name: | XIMATRON IV |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | SIEMENS ELEMA AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-30 |
| Decision Date | 1978-09-14 |