The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Electron Arc Therapy.
| Device ID | K802809 |
| 510k Number | K802809 |
| Device Name: | ELECTRON ARC THERAPY |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-07 |
| Decision Date | 1981-01-07 |