Elekta , Ltd. - FDA 510(k) Cleared Devices

Elekta, Ltd. is a global provider of precision cancer care and radiation therapy solutions. The company operates with a manufacturing facility in Norcross, US, and specializes in advanced treatment delivery systems and imaging technologies for oncology and neurosurgery applications.

Elekta has received 10 FDA 510(k) clearances from 10 total submissions, with all submissions focused on Radiology devices. The company's regulatory clearance history spans from 2005 to 2014. As a historical record, Elekta's cleared devices include treatment planning systems, stereotactic radiosurgery platforms, and imaging solutions that supported precision-guided cancer treatment workflows.

Notable cleared products reflect the company's core expertise in radiation oncology, including systems for treatment delivery, quality assurance, and in-room imaging guidance. These technologies supported adaptive radiotherapy and image-guided interventions across multiple cancer sites and neurosurgical applications.

Explore the complete regulatory record, including specific device names, product codes, and individual clearance dates in the database.