The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Multileaf Collimator, Release 4.0.
| Device ID | K926449 |
| 510k Number | K926449 |
| Device Name: | VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0 |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 3045 HANOVER ST. Palo Alto, CA 94304 -1129 |
| Contact | H Will |
| Correspondent | H Will VARIAN ASSOC., INC. 3045 HANOVER ST. 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 | 1992-12-24 |
| Decision Date | 1995-05-05 |