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Panels › Radiology › Product code LHN · Class 2

System, Radiation Therapy, Charged-Particle, Medical

Regulation 892.5050

4510(k)s in 12 months (93 all time)
3recalls in 12 months (58 all time)
55recalls that name a 510(k)
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Top companies in LHN

Company510(k)sRecalls
Ion Beam Applications S.A.1335
Mevion Medical Systems410
Varian Medical Systems80
Hitachi , Ltd.40
Hitachi, Ltd., Health Care Company40
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha22
Anzai Medical Co., Ltd.30
Brainlab AG30
Hitachi America, Ltd., Particle Therapy Division03
Medcom GmbH30
DateFirm and productCodeLinked 510(k)
Mar 6, 2026Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235
Open, Classified
LHNK163500
Feb 20, 2026Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Open, Classified
LHNK191801
K201042
Feb 20, 2026Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Open, Classified
LHNK232032
Sep 12, 2024Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton
Open, Classified
LHNK232032
Sep 12, 2024Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proto
Open, Classified
LHNK232032
Sep 12, 2024Hitachi America, Ltd., Particle Therapy Division
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proto
Open, Classified
LHNK232032
Sep 10, 2024Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
Open, Classified
LHNK163500
Aug 21, 2024Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Open, Classified
LHNK163500
Jun 3, 2024Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Open, Classified
LHNK163500
Apr 19, 2024Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Open, Classified
LHNK163500
Nov 14, 2023Ion Beam Applications S.A.
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Open, Classified
LHNK163500
May 27, 2022Ion Beam Applications S.A.
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Open, Classified
LHNK163500
Feb 15, 2022Ion Beam Applications S.A.
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Open, Classified
LHNK163500
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
Nov 29, 2021Ion Beam Applications S.A.
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Terminated
LHNK163500
Sep 8, 2021Ion Beam Applications S.A.
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Open, Classified
LHNK061913
May 26, 2021Ion Beam Applications S.A.
Proteus 235-Proton Therapy System
Open, Classified
LHNK101508
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
Jul 17, 2020Ion Beam Applications S.A.
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with loc
Terminated
LHNK163500
May 15, 2020Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Terminated
LHNK120676
K172848
Apr 21, 2020Ion Beam Applications S.A.
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with lo
Terminated
LHNK163500
Apr 15, 2019Hitachi America, Ltd., Power Systems Division
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Terminated
LHNK151132
K152592
Dec 12, 2018Ion Beam Applications S.A.
Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of p
Terminated
LHNK091629
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
Jun 27, 2018Ion Beam Applications S.A.
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized
Terminated
LHNK060695
Jun 20, 2018Ion Beam Applications S.A.
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept
Terminated
LHNK101508
Jan 26, 2018Ion Beam Applications S.A.
Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Terminated
LHNK101508
Dec 5, 2017Ion Beam Applications S.A.
Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for
Terminated
LHNK060695
Nov 17, 2017Ion Beam Applications S.A.
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by
Terminated
LHNK101508
Nov 1, 2017Ion Beam Applications S.A.
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a pr
Terminated
LHNK152224
Oct 19, 2017Ion Beam Applications S.A.
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton
Terminated
LHNK082416
Oct 17, 2017Ion Beam Applications S.A.
Proteus 235, graphite block 8
Terminated
LHNK101508
Jun 30, 2017Elekta, Inc.
MOSAIQ Medical Charged-Particle Radiation Therapy System
Terminated
LHNK141572
Jun 19, 2017Ion Beam Applications S.A.
Proteus 235
Terminated
LHNK152224
May 3, 2017Ion Beam Applications S.A.
Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptibl
Terminated
LHNK152224
Mar 23, 2017Ion Beam Applications S.A.
Proteus 235
Terminated
LHNK101508
Mar 21, 2017Ion Beam Applications S.A.
Proteus 235, Proton Therapy System
Terminated
LHNK152224
Feb 2, 2017Mevion Medical Systems, Inc.
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Terminated
LHNK120676
Dec 13, 2016Ion Beam Applications S.A.
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with local
Terminated
LHNK152224
Oct 28, 2016Ion Beam Applications S.A.
12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respec
Terminated
LHNK132847
Sep 16, 2016Ion Beam Applications S.A.
Proteus ONE and Proteus Plus
Terminated
LHNK152224
Sep 16, 2016Ion Beam Applications S.A.
12C
Terminated
LHNK132847
Aug 7, 2016Ion Beam Applications S.A.
Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Terminated
LHNK132919
May 18, 2016Ion Beam Applications S.A.
Proteus 235 and Proteus ONE proton therapy systems
Terminated
LHNK132919
Apr 20, 2016Mevion Medical Systems, Inc.
MEVION S250 for Proton Radiation Therapy
Terminated
LHNK120676
Apr 11, 2016Ion Beam Applications S.A.
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Terminated
LHNK152224
Feb 8, 2016Mevion Medical Systems, Inc.
MEVION S250 Radiation therapy system
Terminated
LHNK120676
Jul 18, 2015Hitachi America, Ltd., Power Systems Division
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumo
Terminated
LHNK073059
Dec 19, 2014Ion Beam Applications S.A.
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therap
Terminated
LHNK132847

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