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 |