Medical Device Manufacturer · US , Littleton , MA

Mevion Medical Systems, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mevion Medical Systems, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Mar 25, 2026

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Radiology · 176d

Cleared Sep 12, 2025

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

Radiology · 165d