The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Clinac 12/10.
| Device ID | K781174 |
| 510k Number | K781174 |
| Device Name: | CLINAC 12/10 |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-13 |
| Decision Date | 1978-09-14 |