The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Probeam 360° Proton Therapy System.
| Device ID | K221791 |
| 510k Number | K221791 |
| Device Name: | ProBeam 360° Proton Therapy System |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
| Contact | Peter J. Coronado |
| Correspondent | Peter J. Coronado Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-21 |
| Decision Date | 2022-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858991006071 | K221791 | 000 |