{"entity":{"id":"particle-therapy-machines-roadmap","kind":"roadmap","name":"Particle therapy machines: from Loma Linda to proton rooms in a linac vault, carbon gantries and FLASH","aka":[],"tldr":"Proton and carbon-ion machines began as building-sized accelerators and are shrinking towards a single room. This is the chain of models, from Loma Linda's hospital proton centre to compact cyclotrons, upright chairs, superconducting carbon gantries and FLASH.","summary":"Loma Linda's proton system was cleared by the FDA in February 1988 (K872369) and treatments began in October 1990. IBA's proton therapy system followed in 2001 (K983024), Hitachi's PROBEAT in 2006, Varian's in 2010, Sumitomo's in 2013 and ProTom's in 2014. Compactness drove the next decade: Mevion's S250 put the accelerator on the gantry (K120676, 2012) and added scanning with an adaptive aperture in the S250i (2017); IBA's single-room Proteus ONE with a superconducting synchrocyclotron was cleared in 2016 (K152224); Varian's ProBeam 360 brought a smaller gantry and a 226 MeV cyclotron in 2022 (K221791). Upright treatment removed the gantry: P-Cure (2023), Leo Cancer Care's Marie (2025) and Mevion's S250-FIT (2025), which Mevion says fits a standard linac vault.\n\nCarbon-ion machines remain few. Toshiba and Japan's national institute developed a superconducting rotating gantry about 13 m long against 25 m for the conventional design, installed in 2017; Toshiba's two gantry rooms at Yonsei began treating in 2024. Hitachi began heavy-ion treatment in Osaka in 2018. China's first domestically developed carbon-ion system, at Wuwei, was approved by the NMPA in 2019, and a Shanghai 360-degree proton system was registered in 2026. FLASH remains investigational on every platform: FAST-01 and FAST-02 used a modified ProBeam, and IBA and IntraOp state that their FLASH modes are not cleared.","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K872369: Loma Linda University proton beam therapy system (22 February 1988)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K872369"},{"label":"Coutrakon et al., the Loma Linda proton accelerator, treatments began October 1990 (PAC 1991)","url":"https://epaper.kek.jp/p91/PDF/PAC1991_0532.PDF"},{"label":"FDA 510(k) K983024: IBA proton therapy system (12 July 2001)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K983024"},{"label":"FDA 510(k) K053280: Hitachi PROBEAT (9 March 2006)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K053280"},{"label":"FDA 510(k) K101294: Varian PT2 proton therapy system (27 December 2010)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101294"},{"label":"FDA 510(k) K130426: Sumitomo proton therapy system (19 November 2013)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130426"},{"label":"FDA 510(k) K134052: ProTom Radiance 330 (14 March 2014)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K134052"},{"label":"FDA 510(k) K120676: Mevion S250 (4 June 2012)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K120676"},{"label":"FDA 510(k) K172848: Mevion S250i (27 December 2017)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172848"},{"label":"FDA 510(k) K152224: IBA Proteus ONE and Proteus PLUS (9 August 2016)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K152224"},{"label":"FDA 510(k) K221791: Varian ProBeam 360 (1 December 2022)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221791"},{"label":"FDA 510(k) K250986: Mevion S250-FIT (12 September 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250986"},{"label":"Toshiba: superconducting rotating gantry for heavy-ion therapy","url":"https://www.global.toshiba/ww/products-solutions/heavy-ion/topics/gantry-delivery.html"},{"label":"Toshiba: heavy-ion gantry rooms begin treatment at Yonsei (May 2024)","url":"https://www.global.toshiba/ww/news/energy/2024/05/news-20240528-01.html"},{"label":"Hitachi: heavy-ion therapy system begins treatment in Osaka (16 October 2018)","url":"https://www.hitachi.com/en/press/articles/2018/10/1016b/"},{"label":"Chinese Academy of Sciences: China's first self-developed carbon-ion therapy system approved (October 2019)","url":"https://english.cas.cn/head/201910/t20191010_219845.shtml"},{"label":"Chinese Academy of Sciences: 360-degree rotating proton system registered by the NMPA (July 2026)","url":"https://lssf.cas.cn/en/news/nu/202607/t20260702_5114237.html"},{"label":"Siemens and partners: Kiel particle therapy facility discontinued (14 September 2011)","url":"https://assets.new.siemens.com/siemens/assets/api/uuid:1c75f695-43a9-4b4f-90ba-06e48b5e422f/AXX20110983e.pdf"},{"label":"A Siemens IONTRIS proton and carbon-ion system in clinical use in Shanghai (J Radiat Res 2025)","url":"https://doi.org/10.1093/jrr/rraf023"},{"label":"IBA: Proteus ONE, DynamicARC and ConformalFLASH not yet cleared","url":"https://www.iba-protontherapy.com/proteusone"},{"label":"IntraOp: Mobetron FLASH, investigational use only","url":"https://intraop.com/flash/"},{"label":"THERYQ: FLASHDEEP very-high-energy electron device in development","url":"https://www.theryq-alcen.com/flash-radiotherapy-products/flashdeep/"}],"tags":["machines-wave3"],"related":["radiation-roadmap","idea-moon-compact-flash-proton","idea-fund-proton-coverage-with-evidence","idea-fund-flash-evidence-programme","idea-mach-upright-versus-supine-registry"],"cancers":[],"sections":["radiation","devices"],"technologies":["proton-therapy-systems","proton-therapy","carbon-ion-synchrotrons","carbon-ion","upright-radiotherapy-positioning","flash-research-accelerators","flash-rt","proton-arc-therapy","vhee-radiotherapy"],"targets":[],"drugs":[],"companies":["iba","varian","mevion","hitachi","sumitomo-heavy-industries","protom","p-cure","leo-cancer-care","toshiba-energy-systems","theryq","intraop-medical"],"institutions":["severance","qst-hospital","ruijin-hospital","stanford"],"pathways":[],"terms":[],"trials":["fast-01","fast-02"],"people":[],"bottlenecks":["b-surgery-radiation-innovation","b-global-access","b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"steps":[{"era":"1988-2001","title":"A proton centre inside a hospital","description":"Loma Linda's proton beam therapy system was cleared by the FDA in February 1988 (K872369, product code synchrotron) and its accelerator team reported that treatments began in October 1990. Massachusetts General's Northeast Proton Therapy Center (K983332) and IBA's proton therapy system (K983024) were cleared in 2001.","refs":["proton-therapy-systems","proton-therapy","mgh","iba"],"status":"historic"},{"era":"2006-2014","title":"Multi-room centres and pencil-beam scanning","description":"Hitachi's PROBEAT synchrotron (K053280, 2006) and its discrete spot scanning (K073059, 2007), Varian's superconducting cyclotron system (K101294, 2010; named ProBeam in K133191, 2014), Sumitomo's cyclotron (K130426, 2013, scanning added in K160612, 2016) and ProTom's Radiance 330 synchrotron (K134052, 2014) built the multi-room centres, and scanning replaced scattered beams.","refs":["proton-therapy-systems","intensity-modulated-proton-therapy","hitachi","varian","sumitomo-heavy-industries","protom"],"status":"historic"},{"era":"2012-2022","title":"Compact single-room systems","description":"Mevion's S250 (K120676, 2012), described in its summary as \"a low cost, one-room integrated device\", mounted the accelerator on the gantry; the S250i (K172848, 2017) added scanning with an adaptive aperture. IBA's Proteus ONE (K152224, 2016) used a superconducting synchrocyclotron, \"a compact and more affordable alternative to the isochronous cyclotron\". Varian's ProBeam 360 (K221791, 2022) brought a smaller gantry, a compact beam line, a 226 MeV cyclotron and cone-beam CT; Hitachi's PROBEAT-CR (2019) and PROBEAT-FR (2024) added a 360-degree gantry and faster imaging.","refs":["proton-therapy-systems","mevion","iba","varian","hitachi"],"status":"historic"},{"era":"2023-2026","title":"No gantry: upright treatment","description":"P-Cure (K221996, 2023) treats a seated patient in front of a fixed beam; Leo Cancer Care's Marie (K250970, 2025) positions and images upright patients; Mevion's S250-FIT (K250986, 2025) pairs Marie with its compact cyclotron, and Mevion states it fits a standard 110 square metre linac vault. The first S250-FIT patient was treated at Stanford in June 2026, and the system is also CE-marked.","refs":["upright-radiotherapy-positioning","p-cure","leo-cancer-care","mevion","stanford"],"status":"current"},{"era":"2017-2026","title":"Carbon ions: smaller gantries, new countries","description":"Japan's national institute and Toshiba installed a superconducting rotating gantry about 11 m in diameter and 13 m long, against 25 m long for the conventional design, in 2017; Toshiba's Yonsei system began treating with a fixed beam in April 2023 and its first gantry room in May 2024. Hitachi's first heavy-ion system began treatment in Osaka in October 2018. China's NMPA approved the first domestically developed carbon-ion system, at Wuwei, in 2019. Siemens discontinued its proton and carbon facility at Kiel in 2011; its IONTRIS system remains in clinical use in Shanghai. Toshiba has orders from Asan Medical Center and Cleveland Clinic Abu Dhabi.","refs":["carbon-ion-synchrotrons","carbon-ion","toshiba-energy-systems","hitachi","qst-hospital","severance","fuscc","asan-medical-center","cleveland-clinic-abu-dhabi"],"status":"current"},{"era":"2020-2026","title":"FLASH reaches patients, not yet the market","description":"FAST-01 (10 patients, 2020 to 2022) and FAST-02 (10 treated) delivered proton FLASH at 40 Gy per second or more on a modified ProBeam for painful bone metastases, with mild side effects. IBA says its ConformalFLASH and DynamicARC are in development and not cleared; IntraOp says Mobetron FLASH is investigational; THERYQ's FLASHKNiFE is a research device and its very-high-energy electron FLASHDEEP is in development.","refs":["fast-01","fast-02","flash-rt","flash-research-accelerators","proton-arc-therapy","vhee-radiotherapy","theryq","iba","intraop-medical"],"status":"emerging"},{"era":"Next","title":"Cost per patient and proof of benefit","description":"The unmet need is cost and footprint relative to photon radiotherapy, and randomised evidence of which adults benefit. OnCo carries proposals for compact FLASH and proton systems priced like a linac, for pooled coverage with evidence, and for a registry comparing upright and supine treatment.","refs":["idea-moon-compact-flash-proton","idea-fund-proton-coverage-with-evidence","idea-mach-upright-versus-supine-registry","b-drug-pricing"],"status":"emerging"}],"watch":[]},"route":"/roadmaps/particle-therapy-machines-roadmap/","neighbours":{"roadmap":[{"id":"radiation-roadmap","kind":"roadmap","name":"Radiotherapy roadmap: X-rays → shaped beams → fewer fractions, particles and FLASH","route":"/roadmaps/radiation-roadmap/"}],"idea":[{"id":"idea-fund-flash-evidence-programme","kind":"idea","name":"A coordinated FLASH radiotherapy evidence programme with shared dose-rate standards","route":"/ideas/idea-fund-flash-evidence-programme/"},{"id":"idea-mach-upright-versus-supine-registry","kind":"idea","name":"A shared registry comparing upright and lying-down radiotherapy","route":"/ideas/idea-mach-upright-versus-supine-registry/"},{"id":"idea-moon-compact-flash-proton","kind":"idea","name":"Compact FLASH and proton systems at the price of a conventional linac","route":"/ideas/idea-moon-compact-flash-proton/"},{"id":"idea-fund-proton-coverage-with-evidence","kind":"idea","name":"Pooled coverage-with-evidence for proton therapy across all centres","route":"/ideas/idea-fund-proton-coverage-with-evidence/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"}],"technology":[{"id":"carbon-ion-synchrotrons","kind":"technology","name":"Carbon-ion synchrotrons and facilities","route":"/technologies/carbon-ion-synchrotrons/"},{"id":"carbon-ion","kind":"technology","name":"Carbon-ion therapy","route":"/technologies/carbon-ion/"},{"id":"flash-rt","kind":"technology","name":"FLASH radiotherapy","route":"/technologies/flash-rt/"},{"id":"flash-research-accelerators","kind":"technology","name":"FLASH research accelerators (Oriatron, Mobetron FLASH, ProBeam FLASH)","route":"/technologies/flash-research-accelerators/"},{"id":"intensity-modulated-proton-therapy","kind":"technology","name":"Pencil-beam scanning and intensity-modulated proton therapy","route":"/technologies/intensity-modulated-proton-therapy/"},{"id":"proton-arc-therapy","kind":"technology","name":"Proton arc therapy","route":"/technologies/proton-arc-therapy/"},{"id":"proton-therapy","kind":"technology","name":"Proton therapy","route":"/technologies/proton-therapy/"},{"id":"proton-therapy-systems","kind":"technology","name":"Proton therapy machines: cyclotrons, synchrotrons and single-room systems","route":"/technologies/proton-therapy-systems/"},{"id":"upright-radiotherapy-positioning","kind":"technology","name":"Upright radiotherapy positioning (Leo Cancer Care Marie, P-Cure, Mevion S250-FIT)","route":"/technologies/upright-radiotherapy-positioning/"},{"id":"vhee-radiotherapy","kind":"technology","name":"Very-high-energy electron therapy","route":"/technologies/vhee-radiotherapy/"}],"company":[{"id":"hitachi","kind":"company","name":"Hitachi (particle therapy)","route":"/companies/hitachi/"},{"id":"iba","kind":"company","name":"IBA (Ion Beam Applications)","route":"/companies/iba/"},{"id":"intraop-medical","kind":"company","name":"IntraOp Medical","route":"/companies/intraop-medical/"},{"id":"leo-cancer-care","kind":"company","name":"Leo Cancer Care","route":"/companies/leo-cancer-care/"},{"id":"mevion","kind":"company","name":"Mevion Medical Systems","route":"/companies/mevion/"},{"id":"p-cure","kind":"company","name":"P-Cure","route":"/companies/p-cure/"},{"id":"protom","kind":"company","name":"ProTom International","route":"/companies/protom/"},{"id":"sumitomo-heavy-industries","kind":"company","name":"Sumitomo Heavy Industries","route":"/companies/sumitomo-heavy-industries/"},{"id":"theryq","kind":"company","name":"THERYQ","route":"/companies/theryq/"},{"id":"toshiba-energy-systems","kind":"company","name":"Toshiba Energy Systems & Solutions","route":"/companies/toshiba-energy-systems/"},{"id":"varian","kind":"company","name":"Varian (Siemens Healthineers)","route":"/companies/varian/"}],"institution":[{"id":"asan-medical-center","kind":"institution","name":"Asan Medical Center","route":"/institutions/asan-medical-center/"},{"id":"cleveland-clinic-abu-dhabi","kind":"institution","name":"Cleveland Clinic Abu Dhabi","route":"/institutions/cleveland-clinic-abu-dhabi/"},{"id":"fuscc","kind":"institution","name":"Fudan University Shanghai Cancer Center","route":"/institutions/fuscc/"},{"id":"mgh","kind":"institution","name":"Massachusetts General Hospital Cancer Center","route":"/institutions/mgh/"},{"id":"qst-hospital","kind":"institution","name":"QST Hospital (National Institutes for Quantum Science and Technology)","route":"/institutions/qst-hospital/"},{"id":"ruijin-hospital","kind":"institution","name":"Ruijin Hospital, Shanghai Jiao Tong University","route":"/institutions/ruijin-hospital/"},{"id":"severance","kind":"institution","name":"Severance Hospital, Yonsei University","route":"/institutions/severance/"},{"id":"stanford","kind":"institution","name":"Stanford Health Care / Stanford Cancer Institute","route":"/institutions/stanford/"}],"trial":[{"id":"fast-01","kind":"trial","name":"FAST-01 (proton FLASH for bone metastases)","route":"/trials/fast-01/"},{"id":"fast-02","kind":"trial","name":"FAST-02 (proton FLASH for thoracic bone metastases)","route":"/trials/fast-02/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"}]}}