The following data is part of a premarket notification filed by Mevion Medical Systems with the FDA for Mevion S250i Proton Beam Radiation Therapy Device.
| Device ID | K172848 |
| 510k Number | K172848 |
| Device Name: | MEVION S250i Proton Beam Radiation Therapy Device |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | Mevion Medical Systems 300 Foster St. Littleton, MA 01460 |
| Contact | Thomas H. Faris |
| Correspondent | Thomas H. Faris Mevion Medical Systems 300 Foster St. Littleton, MA 01460 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-19 |
| Decision Date | 2017-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864366000124 | K172848 | 000 |