{"entity":{"id":"brachytherapy-iort-machines-roadmap","kind":"roadmap","name":"Brachytherapy, intraoperative and skin radiotherapy machines: afterloaders, theatre linacs and office X-ray units","aka":[],"tldr":"The machines that put radiation inside or right next to a tumour: remote afterloaders that send a radioactive seed down a tube, accelerators small enough for an operating theatre, and low-energy X-ray units for skin cancer. Dated from the FDA records.","summary":"Remote afterloaders keep the radioactive source in a safe and push it through catheters by computer, so staff are not exposed. Nucletron's Selectron and microSelectron HDR appear in the FDA record from 1986 (K852842, K864210), the GammaMed line from 1989 (K891131), Varian's VariSource from the 1990s and GammaMedplus iX in 2007, Isodose Control's Flexitron in 2007 (K070574, now sold by Elekta), Eckert & Ziegler BEBIG's SagiNova in 2015 (K142986), which offers a cobalt-60 source with a longer half-life, and Varian's BRAVOS in 2018 (K181903). Intraoperative machines run from the Mobetron mobile electron linac (1998) and Zeiss INTRABEAM (2005) to LIAC HWL (2018) and INTRABEAM 700 (2025). Superficial X-ray units for skin cancer date in the FDA record from the Therapax 150 (1978) to Sensus's SRT-100 family and Xstrahl's RADiant (2023), and electronic brachytherapy (Xoft Axxent, 2005; Esteya, 2013) replaced the radioactive source with a switchable X-ray tube.","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K864210: microSelectron HDR (26 November 1986)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K864210"},{"label":"FDA 510(k) K891131: GammaMed 12i (7 August 1989)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K891131"},{"label":"FDA 510(k) K071381: GammaMedplus iX (18 July 2007)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K071381"},{"label":"FDA 510(k) K070574: Flexitron (13 April 2007)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K070574"},{"label":"Elekta: Flexitron afterloader","url":"https://www.elekta.com/products/brachytherapy/flexitron/"},{"label":"FDA 510(k) K142986: SagiNova (17 April 2015)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142986"},{"label":"BEBIG Medical: SagiNova HDR afterloader","url":"https://bebigmedical.com/product/hdr-brachytherapy/saginova.html"},{"label":"BEBIG Medical: cobalt-60 in HDR brachytherapy","url":"https://bebigmedical.com/product/Cobalt-60-in-HDR-Brachytherapy.html"},{"label":"FDA 510(k) K181903: BRAVOS afterloader family (3 October 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181903"},{"label":"Siemens Healthineers: BRAVOS afterloader","url":"https://cancercare.siemens-healthineers.com/products/brachytherapy/afterloaders-applicators/bravos"},{"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) K051055: INTRABEAM (23 May 2005)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K051055"},{"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":"FDA 510(k) K781084: Therapax 150A (1978)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K781084"},{"label":"FDA 510(k) K050843: Xoft Axxent (22 December 2005)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K050843"}],"tags":["machines-wave3"],"related":["radiation-roadmap","idea-acc-frugal-hdr-brachytherapy"],"cancers":[],"sections":["radiation","devices"],"technologies":["brachytherapy-afterloaders","brachytherapy","iort-systems","intraoperative-radiotherapy","electronic-brachytherapy-systems","superficial-radiotherapy"],"targets":[],"drugs":[],"companies":["elekta","varian","eckert-ziegler","carl-zeiss-meditec","intraop-medical","sit-sordina-iort","sensus-healthcare","xstrahl","icad"],"institutions":[],"pathways":[],"terms":[],"trials":["targit-a"],"people":[],"bottlenecks":["b-global-access","b-workforce","b-surgery-radiation-innovation"],"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":"1986-2006","title":"Remote afterloaders","description":"Nucletron's Selectron HDR (K852842) and microSelectron HDR (K864210) were cleared in 1986, its second version in 1996 and the v3 in 2006; the GammaMed line from Mick Radio-Nuclear in 1989 passed through later owners to Varian, and Varian's VariSource followed. Remote loading removed staff exposure and high-dose-rate sources made treatment outpatient.","refs":["brachytherapy-afterloaders","brachytherapy","elekta","varian"],"status":"historic"},{"era":"2007-2018","title":"Current afterloader generation","description":"GammaMedplus iX (K071381, 2007), Flexitron (K070574, 2007; Elekta claims up to 30 per cent faster treatment from internal data), SagiNova (K142986, 2015), with a miniaturised cobalt-60 source option, and BRAVOS (K181903, 2018), with a pre-treatment checklist and camera-based quality assurance. microSelectron, VariSource iX and MultiSource no longer appear on their makers' current product lists.","refs":["brachytherapy-afterloaders","elekta","varian","eckert-ziegler"],"status":"current"},{"era":"1998-2025","title":"Radiotherapy in the operating theatre","description":"Mobetron (K981112, 1998), INTRABEAM (K051055, 2005; 600 in 2016; 700 in 2025), LIAC (2012) and LIAC HWL (2018), and NOVAC 11 (2012). TARGIT-A supported low-energy X-ray IORT for selected women; ELIOT found more in-breast recurrence with electrons.","refs":["iort-systems","intraoperative-radiotherapy","targit-a","carl-zeiss-meditec","intraop-medical","sit-sordina-iort"],"status":"current"},{"era":"1978-2023","title":"Skin cancer in the clinic","description":"Superficial and orthovoltage X-ray units, from the Therapax 150A (K781084, 1978) and Gulmay's DARPAC 2000 (1996) to Sensus's SRT-100 (2013), image-guided versions with ultrasound (2013, 2015), SRT-100+ (2018) and Xstrahl's RADiant (2023). Electronic brachytherapy, Xoft Axxent (2005) and Esteya (2013), uses a miniature X-ray tube instead of a radioactive source.","refs":["superficial-radiotherapy","electronic-brachytherapy-systems","sensus-healthcare","xstrahl","icad"],"status":"current"},{"era":"Next","title":"Brachytherapy where it is missing","description":"Brachytherapy is a mandatory part of curative cervical cancer treatment and expertise is declining in some regions. Cobalt-60 afterloaders need fewer source changes, which is the basis of OnCo's proposal for low-cost cobalt brachytherapy in every regional centre.","refs":["idea-acc-frugal-hdr-brachytherapy","cervical","b-global-access","b-workforce"],"status":"emerging"}],"watch":[]},"route":"/roadmaps/brachytherapy-iort-machines-roadmap/","neighbours":{"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-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-acc-frugal-hdr-brachytherapy","kind":"idea","name":"Low-cost cobalt-60 brachytherapy for cervical cancer in every regional centre","route":"/ideas/idea-acc-frugal-hdr-brachytherapy/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"}],"technology":[{"id":"brachytherapy","kind":"technology","name":"Brachytherapy","route":"/technologies/brachytherapy/"},{"id":"electronic-brachytherapy-systems","kind":"technology","name":"Electronic brachytherapy (Xoft Axxent, Esteya)","route":"/technologies/electronic-brachytherapy-systems/"},{"id":"intraoperative-radiotherapy","kind":"technology","name":"Intraoperative radiotherapy (IORT)","route":"/technologies/intraoperative-radiotherapy/"},{"id":"iort-systems","kind":"technology","name":"Intraoperative radiotherapy machines (INTRABEAM, Mobetron, LIAC, NOVAC)","route":"/technologies/iort-systems/"},{"id":"brachytherapy-afterloaders","kind":"technology","name":"Remote afterloaders for HDR brachytherapy","route":"/technologies/brachytherapy-afterloaders/"},{"id":"superficial-radiotherapy","kind":"technology","name":"Superficial and orthovoltage radiotherapy for skin cancer","route":"/technologies/superficial-radiotherapy/"}],"company":[{"id":"carl-zeiss-meditec","kind":"company","name":"Carl Zeiss Meditec","route":"/companies/carl-zeiss-meditec/"},{"id":"eckert-ziegler","kind":"company","name":"Eckert & Ziegler","route":"/companies/eckert-ziegler/"},{"id":"elekta","kind":"company","name":"Elekta","route":"/companies/elekta/"},{"id":"icad","kind":"company","name":"iCAD (RadNet)","route":"/companies/icad/"},{"id":"intraop-medical","kind":"company","name":"IntraOp Medical","route":"/companies/intraop-medical/"},{"id":"sensus-healthcare","kind":"company","name":"Sensus Healthcare","route":"/companies/sensus-healthcare/"},{"id":"sit-sordina-iort","kind":"company","name":"SIT Sordina IORT Technologies","route":"/companies/sit-sordina-iort/"},{"id":"varian","kind":"company","name":"Varian (Siemens Healthineers)","route":"/companies/varian/"},{"id":"xstrahl","kind":"company","name":"Xstrahl","route":"/companies/xstrahl/"}],"trial":[{"id":"targit-a","kind":"trial","name":"TARGIT-A (targeted intraoperative radiotherapy)","route":"/trials/targit-a/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-workforce","kind":"bottleneck","name":"Not enough oncologists, nurses, pathologists, physicists","route":"/bottlenecks/b-workforce/"},{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"}],"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"}]}}