FDA Radiology AI Devices

The Confocal Microprobe Imaging System by Wuxi Hisky Medical Technologies is a high-resolution optical imaging device used in general and plastic surgery. It helps clinicians obtain detailed images of tissue microstructures during procedures, improving diagnosis and surgical outcomes.

The OPXION Optical Skin Viewer is a non-invasive optical coherence tomography system designed to provide real-time visualization of the external tissues of the human body. It generates two-dimensional, cross-sectional, three-dimensional, and en-face images of tissue microstructures, helping clinicians assess skin conditions with high-resolution imaging.

The Arthrex Synergy Vision Endoscopic Imaging System is an advanced camera system used in endoscopic surgery to provide live imaging in visible and near-infrared light. It helps surgeons visualize vessels, blood flow, lymphatic system, and tissues during minimally invasive surgeries, improving surgical precision and patient outcomes.

The FLUOBEAM LX and FLUOBEAM LM are surgical imaging systems that use near infrared fluorescence to help surgeons visualize blood vessels, tissue perfusion, parathyroid glands, lymphatic vessels, and tissues that have absorbed specific dyes during surgery. By enhancing real-time images of tissues, these devices assist clinicians in making precise assessments during complex surgeries, improving patient outcomes.

The OPTOVISION Endoscopic Light Source Unit by Optosurgical LLC is a device designed to provide real-time visible and near-infrared fluorescence imaging during endoscopic procedures. Using indocyanine green (ICG) dye, it helps surgeons visualize vessels, blood flow, tissue perfusion, lymphatic systems, and bile ducts to aid minimally invasive surgeries, improving surgical precision and patient outcomes.

The Edison System is a non-invasive focused ultrasound device designed to mechanically destroy liver tumors using a non-thermal process called histotripsy. Integrated with diagnostic ultrasound imaging, it assists clinicians in precisely targeting and treating liver tumors without surgery, helping to improve liver cancer patient outcomes.

The OTIS 2.1 Optical Coherence Tomography System is a medical imaging device that provides high-resolution, two-dimensional, cross-sectional real-time images of excised human tissue microstructures. It uses non-ionizing optical radiation to create detailed subsurface images, aiding clinicians in evaluating tissue samples. The device automates image acquisition and review, allowing users to identify and annotate regions of interest efficiently, supporting clinical decision-making and improving visualization during tissue evaluation.