FDA Radiology AI Devices

The Tomey Cornea/Anterior Segment OCT (CASIA2) is a medical imaging device that uses optical coherence tomography technology to capture detailed images of the cornea and anterior segment of the eye. It helps clinicians assess eye health and diagnose ocular conditions more accurately by providing high-resolution images of the eye structures.

The Resolve Fundus Camera by Optain Health, Inc. is an automatic eye-fundus camera designed to take high-quality digital images of the retina with or without pupil dilation. It uses infrared tracking and autofocus to capture clear images that aid clinicians in evaluating ocular health. The device enhances diagnosis and monitoring of eye conditions by providing precise, easily accessible retinal images.

The OcuMet Beacon is a scanning LED-based ophthalmoscope that captures detailed black and white infrared and autofluorescence images of the human retina. It helps eye care clinicians by providing high-quality retinal images to assist in diagnosis and management of eye conditions, supporting clinical decisions as an adjunctive imaging modality.

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.

The Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device designed to photograph, display, and store images of the retina under non-mydriatic conditions. It aids clinicians in the evaluation, diagnosis, and documentation of ocular health by providing high quality retinal images.

The IRIS Intelligent Retinal Imaging System is a web-based software that stores, manages, and displays retinal images and diagnostic data from computerized instruments. It allows licensed clinicians to review fundus images and visual field data to evaluate and diagnose retinal conditions such as diabetic retinopathy, glaucoma, and macular degeneration, thereby assisting in patient care and follow-up.