SPECTRALIS with Flex Module
Heidelberg Engineering GmbHThe 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.
Intended Use
Non-contact ophthalmic diagnostic imaging device intended to aid visualization of posterior segment structures of the eye and vasculature of retina and choroid in adults and pediatric patients in supine position.
Technology
Combines confocal laser-scanning ophthalmoscope (cSLO) and spectral-domain optical coherence tomography (SD-OCT) in a mobile Flex Module allowing imaging of supine patients. Uses multiple wavelength lasers and superluminescence diode light sources for high-resolution, non-invasive imaging, and includes adjustable camera arms, power supply, and computer interface.
Performance
Non-clinical safety and software validation performed to FDA standards including electrical safety, electromagnetic compatibility, laser safety, and biocompatibility. Clinical testing involved a prospective observational study comparing the investigational device with a predicate device. Results showed high image quality and similar visualization of anatomic and vascular ocular structures. No adverse events reported. Systematic literature review supports safe and effective use in pediatric and supine patients.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/26/2024
5 months - 2
FDA Approval
10/11/2024
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