CLARUS (700)
Carl Zeiss Meditec, Inc.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.
Intended Use
The CLARUS 700 ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS 700 angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
Technology
The device is a software-controlled, high-resolution ophthalmic imaging system employing slit scanning (Broad Line Fundus Imaging) with sequential RGB LED illumination, near-infrared laser for retina preview, and supports multiple image acquisition modes including fluorescein angiography and indocyanine green angiography. It incorporates a deep learning algorithm for optic nerve head detection to improve image montage and alignment. Hardware changes support new ICGA mode with additional optical filters and laser components.
Performance
Performance testing included biocompatibility testing in accordance with ISO 10993-1, software verification and validation demonstrating the device works as designed, non-clinical bench testing showing system met specifications, and clinical testing confirming high-quality angiography images with simultaneous fluorescein and indocyanine green angiography modes assessed by independent graders.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2024
4 months - 2
FDA Approval
4/17/2025
Other devices from Carl Zeiss Meditec, Inc.
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