FDA Radiology AI Devices

The SPECTRALIS HRA+OCT and variants by Heidelberg Engineering GmbH are non-contact ophthalmic imaging devices combining confocal laser-scanning ophthalmoscopy and spectral-domain optical coherence tomography (SD-OCT). They capture detailed cross-sectional and angiographic images of the eye, aiding clinicians in diagnosing and managing various ocular diseases such as macular degeneration, diabetic retinopathy, and glaucoma. These devices enhance visualization of ocular anatomy and vascular structures, improving clinical evaluation and patient care.

The SPECTRALIS with Flex Module is an advanced eye imaging device designed for non-contact visualization of the posterior segment and vasculature of the retina and choroid in adults and pediatric patients, including those in supine (lying down) position. It helps ophthalmologists detect and monitor various eye conditions by providing high-quality images of eye structures, enabling improved diagnosis and management.