The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Clinac (r) C Series (400c, 600c, 2100c, 2500c).
| Device ID | K862645 |
| 510k Number | K862645 |
| Device Name: | CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
| Contact | Richard M Levy |
| Correspondent | Richard M Levy 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 | 1986-07-11 |
| Decision Date | 1986-10-03 |