The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Probeam Proton Therapy System.
| Device ID | K133191 |
| 510k Number | K133191 |
| Device Name: | PROBEAM PROTON THERAPY SYSTEM |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto, CA 94304 -1129 |
| Contact | Vy Tran |
| Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY Palo Alto, CA 94304 -1129 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858991006019 | K133191 | 000 |
| 00858991006002 | K133191 | 000 |
| 00858991006040 | K133191 | 000 |
| 00858991006033 | K133191 | 000 |
| 00858991006026 | K133191 | 000 |
| 00858991006057 | K133191 | 000 |
| 00858991006064 | K133191 | 000 |