SPECTRALIS HRA+OCT and variants
Heidelberg Engineering GmbHThe 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.
Intended Use
The SPECTRALIS is a non-contact ophthalmic diagnostic imaging device intended for viewing the posterior segment of the eye including two- and three-dimensional imaging, cross-sectional imaging, fundus imaging, fluorescence imaging, autofluorescence imaging and performing measurements of ocular anatomy and lesions, aiding in detection and management of ocular diseases such as age-related macular degeneration, macular edema, diabetic retinopathy, retinal and choroidal vascular diseases, and glaucoma.
Technology
The device combines a confocal laser-scanning ophthalmoscope (cSLO) and a spectral-domain optical coherence tomographer (SD-OCT). It uses multiple laser diodes at specific wavelengths for reflectance, fluorescence, and angiography imaging. The SD-OCT employs an infrared superluminescent diode and spectral interferometer to obtain cross-sectional images. It includes modules for OCT angiography with scan speeds up to 250 kHz, providing high-resolution imaging of ocular anatomy and vascular structures.
Performance
Non-clinical testing including software verification, cybersecurity, electrical safety, electromagnetic compatibility, laser safety, and biocompatibility met relevant standards. Clinical performance testing included a retrospective image grading study with normal and pathology populations, demonstrating the investigational scan types acquired clinically acceptable images and showed substantial equivalence to predicate device scans for image quality, anatomical structure visualization, and identification of vascular abnormalities such as microaneurysms, retinal ischemia, retinal neovascularization, and choroidal neovascularization.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/24/2025
1 month - 2
FDA Approval
5/12/2025
Other devices from Heidelberg Engineering GmbH
- Anterion2024 • 510K
- SPECTRALIS with Flex Module2024 • 510K
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