The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Proton Vision.
| Device ID | K000922 |
| 510k Number | K000922 |
| Device Name: | PROTON VISION |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | VARIAN ASSOC., INC. 3100 HANSEN WAY Palo Alto, CA 94304 -1030 |
| Contact | Linda S Nash |
| Correspondent | Linda S Nash VARIAN ASSOC., INC. 3100 HANSEN WAY Palo Alto, CA 94304 -1030 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-22 |
| Decision Date | 2000-05-24 |