FDA Radiology AI Devices

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.

aiCockpit AI Viewer is a stand-alone software for clinicians that allows viewing and interacting with medical images and AI annotations within a web browser. It supports various imaging manipulation tools and 3D rendering, helping radiologists review findings effectively by displaying images alongside clinical documents and reports.

JLK-AILink is a software platform designed to help healthcare professionals manage, view, and share medical images from various imaging devices like CT and MRI scanners. It enables efficient processing and annotation of images and supports remote access through mobile devices, enhancing clinical workflows and facilitating timely decision-making for patient care.

QuickRad is a web-based PACS (Picture Archiving and Communication System) designed for radiology centers and hospitals. It manages and displays medical images from various scanners including CT, MRI, ultrasound, and X-ray, and allows users to integrate FDA-cleared AI models to assist radiologists by visualizing AI outputs alongside images. This helps clinicians by improving workflow efficiency and providing advanced image viewing and reporting tools.

Identify (4.0) is a medical device by Varian Medical Systems designed to monitor patient motion and respiratory patterns during radiotherapy treatment simulation and delivery. Using high precision surface guided radiation therapy cameras, it helps clinicians accurately position patients and detect motion during treatment, enhancing patient safety and treatment accuracy by synchronizing imaging and radiation delivery with patient motion data.

rTOP is a teleoperation platform that allows medical professionals to remotely operate, assist, review, monitor, and standardize medical imaging and diagnostic devices. It supports video and USB interfaces for human interface devices, enabling read-only or full access control to these devices. The system facilitates remote collaboration and training across healthcare sites, helping clinicians efficiently share expertise and improve workflow, even when not physically present with the imaging equipment.

Contour ProtégéAI+ is a medical imaging software accessory that leverages machine-learning algorithms to automatically create contours of anatomical structures on CT and MR images. It supports clinicians by automating and assisting in image segmentation, which is critical for adaptive therapy, radiation treatment planning, and patient follow-up. The software provides significant time savings and improves contouring consistency, while allowing clinicians to review and edit results as needed.

ZeTTA PACS is a software system designed for hospitals and diagnostic centers to receive, store, retrieve, and display medical images from various modalities such as CT, MRI, ultrasound, and X-ray. It helps healthcare professionals securely access and analyze diagnostic images over hospital networks, supporting efficient image interpretation and management but does not provide diagnostic decision-making functions.

The DigitMI 930 is a PET/CT imaging system that combines positron emission tomography and computed tomography to produce detailed images of metabolic and physiological functions in the body. It helps clinicians detect, localize, evaluate, diagnose, and monitor a wide range of conditions including cancer, cardiovascular disease, and neurological disorders by providing precise anatomical and functional imaging.

The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.