The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian C-series Clinacs Clinac 600c,2100c,2500c.
| Device ID | K904364 |
| 510k Number | K904364 |
| Device Name: | VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Contact | Charles Will |
| Correspondent | Charles Will VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1991-02-27 |