The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Varian High Energy Linear Accelerator.
| Device ID | K112839 |
| 510k Number | K112839 |
| Device Name: | VARIAN HIGH ENERGY LINEAR ACCELERATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 -1129 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 -1129 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2011-11-14 |
| Summary: | summary |