{"entity":{"id":"iort-systems","kind":"technology","name":"Intraoperative radiotherapy machines (INTRABEAM, Mobetron, LIAC, NOVAC)","aka":["IORT machines","Mobile electron linac","INTRABEAM","INTRABEAM 600","INTRABEAM 700","Mobetron","LIAC HWL","NOVAC 11"],"tldr":"Machines small enough to wheel into an operating theatre, so a surgeon and radiation oncologist can give one dose of radiation to the tumour bed while the patient is still under anaesthetic. Some use low-energy X-rays from a probe, others a mobile electron beam.","summary":"Two kinds of machine deliver intraoperative radiotherapy. Low-energy X-ray devices put a miniature 50 kV X-ray source inside an applicator placed in the cavity: Zeiss INTRABEAM (FDA 510(k) K051055, 23 May 2005), INTRABEAM 600 (K162568, 2016) and INTRABEAM 700 (K241174, 10 January 2025), which Zeiss describes as offering \"Robotic-assisted Precision\" and sells only in the United States so far. Mobile electron linacs are self-shielded accelerators on a movable stand: IntraOp's Mobetron (K981112, 24 July 1998, the only IntraOp 510(k) in the FDA database), Sordina's LIAC (K110840, 2012) and its successor LIAC HWL (K172961, 2018), which the maker calls \"the latest and most advanced model of SIT mobile electron linear accelerators\" at 4 to 12 MeV, and NOVAC 11 (K112286, 2012), which the maker describes as the descendant of NOVAC 7, designed in 1997. Electronic brachytherapy sources such as Xoft Axxent are also used in the operating theatre and have their own record.\n\nThe two breast trials that tested the approaches reached different answers. TARGIT-A, with INTRABEAM, met its non-inferiority margin for local recurrence at five years in the group treated during lumpectomy (2.11 against 0.95 per cent). ELIOT, with electrons, found more in-breast recurrence than whole-breast radiotherapy (12.6 against 2.4 per cent at 15 years) with no difference in overall survival, and its authors concluded that it \"should be offered to selected patients at low-risk\". Outside breast cancer the machines give a boost to close margins in rectal cancer, retroperitoneal sarcoma and pancreatic cancer. IntraOp states that the FLASH (ultra-high dose rate) mode of the Mobetron is investigational and not cleared for sale in the United States.","status":"established","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K051055: INTRABEAM System (23 May 2005)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051055"},{"label":"FDA 510(k) K162568: INTRABEAM 600 (15 December 2016)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162568"},{"label":"FDA 510(k) K241174: INTRABEAM 700 (10 January 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241174"},{"label":"ZEISS: INTRABEAM 700","url":"https://www.zeiss.com/meditec/en/products/intrabeam-700.html"},{"label":"FDA 510(k) K981112: Mobetron (24 July 1998)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K981112"},{"label":"FDA 510(k) K110840: LIAC (17 April 2012)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K110840"},{"label":"FDA 510(k) K172961: LIAC HWL (11 June 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172961"},{"label":"SIT Sordina IORT Technologies: LIAC HWL","url":"https://soiort.com/liac-hwl-radioprotection/"},{"label":"FDA 510(k) K112286: NOVAC 11 (19 April 2012)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K112286"},{"label":"SIT Sordina IORT Technologies: NOVAC 11","url":"https://soiort.com/novac-11/"},{"label":"IntraOp: Mobetron FLASH, investigational use only","url":"https://intraop.com/flash/"},{"label":"Vaidya et al., TARGIT-A long-term results (BMJ 2020)","url":"https://doi.org/10.1136/bmj.m2836"},{"label":"Orecchia et al., ELIOT long-term results (Lancet Oncology 2021)","url":"https://doi.org/10.1016/s1470-2045(21)00080-2"}],"tags":["machines-wave3"],"related":[],"cancers":["breast-cancer","rectal-cancer","retroperitoneal-sarcoma","pancreatic"],"sections":["radiation","devices","surgery"],"technologies":["intraoperative-radiotherapy","electron-beam-therapy-systems","electronic-brachytherapy-systems","flash-research-accelerators"],"targets":[],"drugs":[],"companies":["carl-zeiss-meditec","intraop-medical","sit-sordina-iort"],"institutions":[],"pathways":[],"terms":[],"trials":["targit-a"],"people":[],"bottlenecks":[],"keyPapers":["paper-vaidya-bmj","paper-orecchia-lancet-oncol"],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"A low-energy X-ray probe or a self-shielded mobile electron linac delivers a single large dose to the exposed tumour bed while organs at risk are moved aside or shielded, using the steep fall-off of low-energy photons or of electrons.","strengths":["Completes radiotherapy during surgery for selected patients","Self-shielded units work in a standard operating theatre","Boost to the margin at highest risk with organs moved out of the way"],"limitations":["Breast trials gave different results by technique; more in-breast recurrence than whole-breast treatment in ELIOT","Pathology is not known when the dose is given","Theatre time, staffing and the machine are added costs"],"since":1998},"route":"/technologies/iort-systems/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"},{"id":"retroperitoneal-sarcoma","kind":"cancer","name":"Retroperitoneal sarcoma","route":"/cancers/retroperitoneal-sarcoma/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"electron-beam-therapy-systems","kind":"technology","name":"Electron beam therapy systems (linac electrons, total skin electron units, mobile electron IORT)","route":"/technologies/electron-beam-therapy-systems/"},{"id":"electronic-brachytherapy-systems","kind":"technology","name":"Electronic brachytherapy (Xoft Axxent, Esteya)","route":"/technologies/electronic-brachytherapy-systems/"},{"id":"flash-research-accelerators","kind":"technology","name":"FLASH research accelerators (Oriatron, Mobetron FLASH, ProBeam FLASH)","route":"/technologies/flash-research-accelerators/"},{"id":"intraoperative-radiotherapy","kind":"technology","name":"Intraoperative radiotherapy (IORT)","route":"/technologies/intraoperative-radiotherapy/"}],"company":[{"id":"carl-zeiss-meditec","kind":"company","name":"Carl Zeiss Meditec","route":"/companies/carl-zeiss-meditec/"},{"id":"intraop-medical","kind":"company","name":"IntraOp Medical","route":"/companies/intraop-medical/"},{"id":"sit-sordina-iort","kind":"company","name":"SIT Sordina IORT Technologies","route":"/companies/sit-sordina-iort/"}],"trial":[{"id":"targit-a","kind":"trial","name":"TARGIT-A (targeted intraoperative radiotherapy)","route":"/trials/targit-a/"}],"paper":[{"id":"paper-orecchia-lancet-oncol","kind":"paper","name":"Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial","route":"/key-papers/paper-orecchia-lancet-oncol/"},{"id":"paper-vaidya-bmj","kind":"paper","name":"Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial","route":"/key-papers/paper-vaidya-bmj/"}],"roadmap":[{"id":"brachytherapy-iort-machines-roadmap","kind":"roadmap","name":"Brachytherapy, intraoperative and skin radiotherapy machines: afterloaders, theatre linacs and office X-ray units","route":"/roadmaps/brachytherapy-iort-machines-roadmap/"}]}}