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)
Top companies in LHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ion Beam Applications S.A. | 13 | 35 |
| Mevion Medical Systems | 4 | 10 |
| Varian Medical Systems | 8 | 0 |
| Hitachi , Ltd. | 4 | 0 |
| Hitachi, Ltd., Health Care Company | 4 | 0 |
| Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2 | 2 |
| Anzai Medical Co., Ltd. | 3 | 0 |
| Brainlab AG | 3 | 0 |
| Hitachi America, Ltd., Particle Therapy Division | 0 | 3 |
| Medcom GmbH | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2026 | Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235 Open, Classified |
LHN | K163500 |
| Feb 20, 2026 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Brand Name: Hitachi Proton Beam Therapy
REF: PROBEAT-CR Open, Classified |
LHN | K191801 K201042 |
| Feb 20, 2026 | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Brand Name: Hitachi Proton Beam Therapy System
Ref: PROBEAT-FR Open, Classified |
LHN | K232032 |
| Sep 12, 2024 | Hitachi 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 |
LHN | K232032 |
| Sep 12, 2024 | Hitachi 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 |
LHN | K232032 |
| Sep 12, 2024 | Hitachi 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 |
LHN | K232032 |
| Sep 10, 2024 | Ion 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 |
LHN | K163500 |
| Aug 21, 2024 | Ion 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 |
LHN | K163500 |
| Jun 3, 2024 | Ion 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 |
LHN | K163500 |
| Apr 19, 2024 | Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. Open, Classified |
LHN | K163500 |
| Nov 14, 2023 | Ion 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 |
LHN | K163500 |
| May 27, 2022 | Ion 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 |
LHN | K163500 |
| Feb 15, 2022 | Ion 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 |
LHN | K163500 |
| Feb 1, 2022 | Mevion Medical Systems, Inc. Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) Open, Classified |
LHN | K120676 K172848 |
| Nov 29, 2021 | Ion Beam Applications S.A. Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Terminated |
LHN | K163500 |
| Sep 8, 2021 | Ion 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 |
LHN | K061913 |
| May 26, 2021 | Ion Beam Applications S.A. Proteus 235-Proton Therapy System Open, Classified |
LHN | K101508 |
| Oct 19, 2020 | Mevion 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 |
LHN | K172848 |
| Jul 17, 2020 | Ion 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 |
LHN | K163500 |
| May 15, 2020 | Mevion Medical Systems, Inc. MEVION S250i, MEVION S250; Proton Radiation Treatment System Terminated |
LHN | K120676 K172848 |
| Apr 21, 2020 | Ion 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 |
LHN | K163500 |
| Apr 15, 2019 | Hitachi America, Ltd., Power Systems Division PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. Terminated |
LHN | K151132 K152592 |
| Dec 12, 2018 | Ion 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 |
LHN | K091629 |
| Oct 1, 2018 | Mevion Medical Systems, Inc. MEVION S250i Terminated |
LHN | K172848 |
| Jun 29, 2018 | Mevion 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 |
LHN | K120676 K172848 |
| Jun 27, 2018 | Ion 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 |
LHN | K060695 |
| Jun 20, 2018 | Ion 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 |
LHN | K101508 |
| Jan 26, 2018 | Ion 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 |
LHN | K101508 |
| Dec 5, 2017 | Ion 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 |
LHN | K060695 |
| Nov 17, 2017 | Ion 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 |
LHN | K101508 |
| Nov 1, 2017 | Ion 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 |
LHN | K152224 |
| Oct 19, 2017 | Ion 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 |
LHN | K082416 |
| Oct 17, 2017 | Ion Beam Applications S.A. Proteus 235, graphite block 8 Terminated |
LHN | K101508 |
| Jun 30, 2017 | Elekta, Inc. MOSAIQ Medical Charged-Particle Radiation Therapy System Terminated |
LHN | K141572 |
| Jun 19, 2017 | Ion Beam Applications S.A. Proteus 235 Terminated |
LHN | K152224 |
| May 3, 2017 | Ion 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 |
LHN | K152224 |
| Mar 23, 2017 | Ion Beam Applications S.A. Proteus 235 Terminated |
LHN | K101508 |
| Mar 21, 2017 | Ion Beam Applications S.A. Proteus 235, Proton Therapy System Terminated |
LHN | K152224 |
| Feb 2, 2017 | Mevion Medical Systems, Inc. MEVION S250-Proton Radiation Therapy
Product Usage:
Proton Radiation Therapy Terminated |
LHN | K120676 |
| Dec 13, 2016 | Ion 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 |
LHN | K152224 |
| Oct 28, 2016 | Ion 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 |
LHN | K132847 |
| Sep 16, 2016 | Ion Beam Applications S.A. Proteus ONE and Proteus Plus Terminated |
LHN | K152224 |
| Sep 16, 2016 | Ion Beam Applications S.A. 12C Terminated |
LHN | K132847 |
| Aug 7, 2016 | Ion 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 |
LHN | K132919 |
| May 18, 2016 | Ion Beam Applications S.A. Proteus 235 and Proteus ONE proton therapy systems Terminated |
LHN | K132919 |
| Apr 20, 2016 | Mevion Medical Systems, Inc. MEVION S250 for Proton Radiation Therapy Terminated |
LHN | K120676 |
| Apr 11, 2016 | Ion Beam Applications S.A. The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE)
Proteus 235, Beam Management System (PBS) Terminated |
LHN | K152224 |
| Feb 8, 2016 | Mevion Medical Systems, Inc. MEVION S250 Radiation therapy system Terminated |
LHN | K120676 |
| Jul 18, 2015 | Hitachi 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 |
LHN | K073059 |
| Dec 19, 2014 | Ion 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 |
LHN | K132847 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.