Sensus IORT System

The Sensus IORT System is a therapeutic X-ray device designed for intraoperative radiotherapy (IORT), delivering precise radiation doses directly to tumor sites during surgery. Classified as a Class II medical device, it is intended for use in radiology settings to provide targeted radiation therapy while minimizing exposure to surrounding healthy tissue. The system leverages intraoperative delivery to enhance localized control of cancerous growths, particularly in complex or high-risk cases where traditional external beam radiotherapy may be less effective. Its design aligns with radiology-based interventions, ensuring integration with surgical workflows for optimal clinical outcomes.

The Sensus IORT System is supplied as a reusable medical device, with components and accessories intended for single-use or as specified by the manufacturer. It is not MRI-compatible and must be used in environments compliant with radiation safety protocols. The system includes multiple reference codes (e.g., 3009732568, 3023344262) and is regulated under FDA 510(k) clearance (K182641) as a substantially equivalent device to a predicate, falling under regulation number 892.5900. Storage and handling follow manufacturer guidelines to maintain sterility and functionality, ensuring safe intraoperative use in radiology departments.