The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Ximatron C-series Radiotherapy Treatment St.
| Device ID | K853349 |
| 510k Number | K853349 |
| Device Name: | VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Contact | Milton D Siegel |
| Correspondent | Milton D Siegel VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-10-28 |