The following data is part of a premarket notification filed by Varian Medical Systems, Oncology Systems with the FDA for Vitesse 3.0.
| Device ID | K123152 |
| 510k Number | K123152 |
| Device Name: | VITESSE 3.0 |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 911 HANSEN WAY Palo Alto, CA 94304 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS 911 HANSEN WAY Palo Alto, CA 94304 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-09 |
| Decision Date | 2012-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850800006012 | K123152 | 000 |