{"entity":{"id":"sensus-healthcare","kind":"company","name":"Sensus Healthcare","aka":["Sensus"],"tldr":"Sensus Healthcare makes a family of superficial X-ray machines used in dermatology offices to treat basal and squamous cell skin cancers and keloids without surgery.","summary":"Sensus Healthcare of Boca Raton holds FDA clearances for a superficial radiotherapy system (K123985, 2013), image-guided versions with high-frequency ultrasound (K131582, 2013; K150037, 2015), an updated model (K173425, 2018) and an intraoperative X-ray system (K182641, 2019). It markets its image-guided model as \"the only FDA cleared IG-SRT\", a maker's claim; which clearance covers it is not stated. An earlier clearance under the same model name (K063456, 2007) is held by Topex, Inc.; whether Topex was Sensus's predecessor was not confirmed. The models are listed on the superficial radiotherapy record.","asOf":"2026-11-04","links":[{"label":"Official website","url":"https://sensushealthcare.com/"},{"label":"FDA 510(k) K123985: SRT-100 (14 May 2013)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K123985"},{"label":"FDA 510(k) K150037: image-guided superficial radiotherapy with ultrasound (16 October 2015)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K150037"},{"label":"FDA 510(k) K173425: SRT-100+ (23 March 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173425"},{"label":"Sensus Healthcare: SRT-100+","url":"https://sensushealthcare.com/srt-100-plus/"},{"label":"Sensus Healthcare: SRT-100 Vision","url":"https://sensushealthcare.com/srt-100-vision/"}],"tags":["machines-wave3"],"related":[],"cancers":[],"sections":["radiation","devices"],"technologies":["superficial-radiotherapy","electronic-brachytherapy-systems"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"hq":"Boca Raton, FL","country":"US","companyType":"devices","website":"https://sensushealthcare.com/","investors":[],"funding":[]},"route":"/companies/sensus-healthcare/","neighbours":{"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"radiation","kind":"section","name":"Radiation Therapy","route":"/fronts/radiation/"}],"technology":[{"id":"electronic-brachytherapy-systems","kind":"technology","name":"Electronic brachytherapy (Xoft Axxent, Esteya)","route":"/technologies/electronic-brachytherapy-systems/"},{"id":"superficial-radiotherapy","kind":"technology","name":"Superficial and orthovoltage radiotherapy for skin cancer","route":"/technologies/superficial-radiotherapy/"}],"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/"}]}}