FDA Radiology AI Devices

PeekMed web is an AI-powered software system that helps healthcare professionals perform pre-operative planning for various surgical procedures using patients' imaging studies. It operates in 2D and 3D environments with support for musculoskeletal regions and incorporates automated AI models for bone segmentation and landmarking, improving efficiency and accuracy in surgical planning.

The Broncho Videoscope System from Scivita Medical Technology Co. consists of single-use bronchoscopes and endoscopic image processors designed for endoscopic diagnosis and treatment within the respiratory system, including the trachea, bronchi, and lungs. This system provides real-time visualization on monitors, enabling clinicians to observe, diagnose, and treat respiratory conditions effectively in hospital settings.

The Klarity SGRT System is a non-invasive, surface-guided radiation therapy device that uses 3D cameras and advanced software to continuously monitor patient positioning and breathing during radiotherapy. It helps clinicians accurately position patients and track respiratory motion to optimize treatment delivery and minimize radiation exposure to healthy tissues.

MAIA is a medical imaging device used to take detailed digital images of the human retina without the need for pharmacological dilation. It uses confocal imaging and white light illumination to capture sharp, naturally colored retinal images, aiding clinicians in retina examination. The device also features pupil tracking and automatic perimetry for measuring retinal sensitivity and fixation analysis, improving accuracy in eye diagnostics.

PLANET Onco Dose (3.2) is a specialized software platform designed for medical professionals in molecular imaging and oncology. It helps manage and analyze various anatomical and functional medical images such as CT, MRI, SPECT, PET, and others. The software supports tumor and normal tissue segmentation, image co-registration, therapy response evaluation, and computes radiation doses at a voxel level for radionuclide-based therapies, improving treatment planning and patient care.

Viewer+ is an internet browser-based software intended to help pathologists view and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded tissue. It aids in primary diagnosis by allowing image navigation, annotation, and measurement, ultimately supporting pathology evaluations digitally.

The Bronchoscope System by Shenzhen Sanping Image Technology Co. is a single-use flexible bronchoscope designed for use in hospital environments for adult patients. It works with an electronic endoscope imaging processor that captures images inside the airways and tracheobronchial tree using a CMOS image sensor and LED light source, then processes and displays these images on a monitor. This system helps clinicians perform endoscopic diagnosis and treatments safely and effectively with single-use, sterile instruments to reduce infection risks.

Op.n Navigation by Ecential Robotics is a surgical navigation system designed to assist surgeons during spinal surgery. It uses intra-operative 3D imaging to help accurately position surgical instruments and implants like pedicle screws in the thoracolumbar spine. This technology improves surgical precision and patient outcomes by providing real-time navigation based on detailed imaging.

The SPINEART Navigation Instrument System is a surgical tool used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws. It integrates with the eCential Op.n PERLA® TL Navigation System, which uses intraoperative 3D imaging, to improve surgical precision in both open and minimally invasive procedures.

The Philips IntelliSite Pathology Solution 5.1 is an automated system that creates, views, and manages digital images of pathology slides prepared from tissue samples. It aids pathologists by providing digital visualization of glass slides, facilitating the review and interpretation of surgical pathology in a digital format, thus modernizing and streamlining pathology workflows.