The following data is part of a premarket notification filed by Mevion Medical Systems with the FDA for S-250 Proton Beam Radiation Therapy System.
| Device ID | K120676 |
| 510k Number | K120676 |
| Device Name: | S-250 PROTON BEAM RADIATION THERAPY SYSTEM |
| 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 | 2012-03-05 |
| Decision Date | 2012-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864366000100 | K120676 | 000 |