FDA Radiology AI Devices

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.

The CLARUS 700 is an advanced ophthalmic imaging device designed to capture high-resolution images of the retina and ocular structures to aid clinicians in diagnosing and monitoring eye diseases. It supports true color, autofluorescence, fluorescein angiography, and indocyanine green angiography imaging modes over wide fields of view. The device incorporates AI algorithms for optic nerve head detection to improve image alignment and provides tools for image annotation and measurement, facilitating comprehensive eye health analysis.

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 AEYE-DS device helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes by analyzing retinal images taken by specific fundus cameras. It uses AI technology to analyze the images and provides diagnostic screening results, improving early detection and management of diabetic eye disease.

EyeArt v2.2.0 is an AI-based software device designed to automatically detect more than mild and vision-threatening diabetic retinopathy in retinal fundus images. It assists healthcare providers by analyzing images captured from specific retinal cameras and providing diagnostic screening results to help identify retinal disease in adults with diabetes, facilitating early detection and treatment.

AEYE-DS is an AI-powered retinal diagnostic software that helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes using fundus images from a Topcon NW400 camera. It improves screening efficiency by analyzing images to identify disease presence, helping to guide timely patient care.

IDx-DR v2.3 is an AI-based diagnostic software that automatically detects more than mild diabetic retinopathy from retinal images captured with a Topcon NW400 fundus camera. It helps healthcare providers identify patients who need referral to eye care professionals, improving timely diagnosis and management of diabetic retinopathy.

IDx-DR is an AI software device designed to help healthcare providers automatically detect more than mild diabetic retinopathy in diabetic adult patients using retinal fundus images. It assists clinicians by analyzing images captured from a specialized retinal camera and providing a diagnostic screening result, thus potentially improving early detection and management of diabetic eye disease.