ClearanceBrief
510(k) K120676 ยท LHN System, Radiation Therapy, Charged-Particle, Medical

S-250 PROTON BEAM RADIATION THERAPY SYSTEM

ApplicantMevion Medical Systems, Littleton MA, US
DecisionSubstantially Equivalent, Jun 4, 2012
ReceivedMar 5, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K120676

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		 LHNNone listed
Jun 23, 2020Mevion Medical Systems, Inc.
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Terminated		 LHONone listed
May 15, 2020Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Terminated		 LHNNone listed
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		 LHNNone listed
Feb 2, 2017Mevion Medical Systems, Inc.
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Terminated		 LHNNone listed
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Terminated		 MUJNone listed
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
Terminated		 MUJNone listed
Nov 15, 2016Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
Terminated		 MUJNone listed
Apr 20, 2016Mevion Medical Systems, Inc.
MEVION S250 for Proton Radiation Therapy
Terminated		 LHNNone listed
Feb 8, 2016Mevion Medical Systems, Inc.
MEVION S250 Radiation therapy system
Terminated		 LHNNone listed
Dec 12, 2014Mevion Medical Systems, Inc.
MEVION S250, used for proton radiation therapy.
Terminated		 LHNNone listed
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		 LHNNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.