The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Multileaf Collimator.
| Device ID | K943224 |
| 510k Number | K943224 |
| Device Name: | VARIAN MULTILEAF COLLIMATOR |
| Classification | Accelerator, Linear, Medical |
| Applicant | VARIAN ASSOC., INC. 911 HANSEN WAY Palo Alto, CA 94303 |
| Contact | Charles H Will |
| Correspondent | Charles H Will VARIAN ASSOC., INC. 911 HANSEN WAY 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 | 1994-07-05 |
| Decision Date | 1996-02-02 |