# Mevion Medical Systems

- Location (FDA's records): Littleton, MA
- FDA decisions: 4 (2012–2026): 4 510(k) clearances
- Names in FDA's records: Mevion Medical Systems (2); Mevion Medical Systems, Inc. (2)
- Product codes: LHN (4)
- 510(k) review time since 2016: median 165 days, against 190 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ion Beam Applications S.A.: 4 (https://510kreport.com/company/ion-beam-applications)
- Ion Beam Application S.A.: 1 (https://510kreport.com/company/ion-beam-application)
- Massachusetts General Hospital: 1 (https://510kreport.com/company/massachusetts-general-hospital)
- Loma Linda University Medical Center: 1 (https://510kreport.com/company/loma-linda-university-medical-center)
- Indiana University Cyclotron Facility: 1 (https://510kreport.com/company/indiana-university-cyclotron-facility)
- Hitachi, Ltd., Power Systems Group: 1 (https://510kreport.com/company/hitachi-power-systems-group)
- Varian Medical Systems, Oncology Systems: 1 (https://510kreport.com/company/varian-medical-systems-oncology-systems)

## Firms that cite its devices most
- Ion Beam Application S.A.: 1 (https://510kreport.com/company/ion-beam-application)

## Its most-cited devices
- K120676: S-250 Proton Beam Radiation Therapy System (2012), cited by 2
- K172848: MEVION S250i Proton Beam Radiation Therapy Device (2017), cited by 1
- K250986: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (2025), cited by 1

## Recent decisions
- K253406: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (Mar 25, 2026)
- K250986: S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (Sep 12, 2025)
- K172848: MEVION S250i Proton Beam Radiation Therapy Device (Dec 27, 2017)
- K120676: S-250 Proton Beam Radiation Therapy System (Jun 4, 2012)

Source page: https://510kreport.com/company/mevion-medical-systems