ClearanceBrief
Company ยท US

Mevion Medical Systems, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (1 in 12 months)
14recalls (0 in 12 months)
14recalls that name a 510(k)

Product codes

CodeDeviceRecords
LHNSystem, Radiation Therapy, Charged-Particle, Medical14
MUJSystem, Planning, Radiation Therapy Treatment3
LHOInstrument, Quality-Assurance, Radiologic1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 25, 2026K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
Mevion Medical Systems, Inc.
LHN
Sep 12, 2025K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
Mevion Medical Systems, Inc.
LHN
Dec 27, 2017K172848MEVION S250i Proton Beam Radiation Therapy Device
Mevion Medical Systems
LHN
Jun 4, 2012K120676S-250 PROTON BEAM RADIATION THERAPY SYSTEM
Mevion Medical Systems
LHN

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 1, 2022Mevion Medical Systems, Inc.
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Open, Classified		 LHNK120676
K172848
Oct 19, 2020Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to tr
Terminated		 LHNK172848
Jun 23, 2020Mevion Medical Systems, Inc.
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Terminated		 LHOK120676
May 15, 2020Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Terminated		 LHNK120676
K172848
Oct 1, 2018Mevion Medical Systems, Inc.
MEVION S250i
Terminated		 LHNK172848
Jun 29, 2018Mevion Medical Systems, Inc.
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptib
Terminated		 LHNK120676
K172848
Feb 2, 2017Mevion Medical Systems, Inc.
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Terminated		 LHNK120676
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Terminated		 MUJK120676
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
Terminated		 MUJK120676
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Terminated		 MUJK120676
Apr 20, 2016Mevion Medical Systems, Inc.
MEVION S250 for Proton Radiation Therapy
Terminated		 LHNK120676
Feb 8, 2016Mevion Medical Systems, Inc.
MEVION S250 Radiation therapy system
Terminated		 LHNK120676
Dec 12, 2014Mevion Medical Systems, Inc.
MEVION S250, used for proton radiation therapy.
Terminated		 LHNK120676
Mar 22, 2014Mevion Medical Systems, Inc.
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Terminated		 LHNK120676
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