CLARUS

by Carl Zeiss Meditec  · Based in Germany → — High-definition Ultra-widefield Retinal Imaging System with True Color
Ophthalmology
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Regulatory Status Disclosed

Overview

CLARUS by Carl Zeiss Meditec is an advanced ultra-widefield (UWF) retinal imaging system designed for eye care specialists. It provides high-resolution, true-color images of the fundus, from the macula to the far periphery, aiding in the diagnosis and monitoring of various eye diseases. The system integrates multiple imaging modalities, including True Color, Fundus Autofluorescence (FAF-Blue and FAF-Green), Fluorescein Angiography (FA), and Indocyanine Green Angiography (ICGA).

CLARUS utilizes Broad Line Fundus Imaging (BLFI) technology to capture clear images by minimizing scattering and reflections, and employs broad-spectrum LEDs for natural-looking true-color rendering. It is designed for patient comfort with ergonomic features and aims to maximize workflow efficiency through features like QuickCompare for side-by-side pathology comparison, PrecisionFocus for optimizing focus in regions of interest, and GazePoint AI technology for accurate gaze angle detection and distortion adjustment.

The system is part of the broader ZEISS Medical Ecosystem, which aims to integrate devices, data, and applications to optimize clinical management.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • True Color Ultra-widefield Imaging (up to 200u00b0 with auto-merge)
  • High-resolution Clarity (down to 7 microns)
  • Multiple Imaging Modalities (FAF-Blue, FAF-Green, FA, ICGA)
  • GazePoint AI Technology (for accurate gaze angle and distortion adjustment)
  • AutoBright Software (optimizes image brightness throughout angiogram)
  • QuickCompare (side-by-side comparison of pathology changes)
  • PrecisionFocus (optimize focus in regions of interest without losing macula focal point)
  • Broad Line Fundus Imaging (BLFI)
  • ETDRS Grid Overlay
  • Ergonomic Design for Patient Comfort

Use Cases

  • Diagnosis and monitoring of diabetic retinopathy
  • Detection of retinal diseases (e.g., uveitis, choroidal masses, retinal tears, detachments, peripheral ischemia)
  • Evaluation of macular degeneration (e.g., dry AMD, geographic atrophy)
  • Glaucoma assessment and monitoring
  • Visualization of vascular structures of the retina and choroid
  • Documentation of ocular disorders and lesions where color is essential

What Physicians Need to Know

Retinal Image Analysis (Fundus/OCT)
CLARUS is an ultra-widefield fundus camera that captures true color, autofluorescence (FAF-Blue, FAF-Green), infrared (IR), fluorescein angiography (FA), and indocyanine green angiography (ICGA) images. It provides high-resolution imaging from the macula to the far periphery, with a resolution down to 7 microns. While CLARUS itself does not perform OCT, its images can be integrated and reviewed alongside OCT data from ZEISS CIRRUS devices within the ZEISS Retina Workplace software for a comprehensive view of retinal pathology.
Diabetic Retinopathy Screening Accuracy
The CLARUS 700 demonstrates strong performance in diabetic retinopathy (DR) screening. In studies, it achieved 94.2% sensitivity for detecting any DR and 86% sensitivity for referable DR. Its specificity for any DR was 87.3% and for referable DR was 92.8%. It also produced fewer unassessable images compared to other ultra-widefield cameras, enhancing reliability in screening programs.
Glaucoma Detection
CLARUS aids in the early detection and monitoring of glaucoma by providing high-resolution, true-color images of the optic disc. Its review software facilitates comparing images over time, which is crucial for identifying subtle glaucomatous changes. The system can integrate with ZEISS Glaucoma Workplace for a comprehensive assessment.
Age-Related Macular Degeneration Screening
CLARUS assists in the detection of Age-Related Macular Degeneration (AMD), including neovascular AMD. It has shown a high sensitivity of 94.4% and a specificity of 89.5% for detecting neovascular AMD. The true-color imaging and high resolution help in visualizing choroidal lesions, drusen, hard exudates, and macular edema.
Autonomous vs Assistive Diagnosis
CLARUS incorporates AI-based features like GazePoint technology, which uses a deep learning algorithm to identify and use the optic nerve as a focal point for montaging, and AutoBright software for optimizing image brightness. PrecisionFocus also uses AI to assist in optimizing focus. These features are designed to enhance image capture and workflow efficiency, serving as assistive tools for the clinician rather than providing autonomous diagnoses.
Point-of-Care Deployment
The CLARUS system is designed for ease of use and patient comfort, often allowing for non-mydriatic imaging, which eliminates the need for dilating eye drops in most cases. The imaging process is quick, typically less than 2 minutes, making it suitable for efficient point-of-care deployment and improving patient flow.
Screening Program Integration
CLARUS has been evaluated in large-scale diabetic eye screening programs, demonstrating good performance in detecting referable DR and producing fewer unassessable images, which is beneficial for widespread community-based screening efforts. Its ability to capture high-quality images without dilation further facilitates integration into screening workflows.
Sensitivity & Specificity Data
For any Diabetic Retinopathy: Sensitivity 94.2%, Specificity 87.3%. For referable Diabetic Retinopathy: Sensitivity 86%, Specificity 92.8%. For Neovascular Age-Related Macular Degeneration: Sensitivity 94.4%, Specificity 89.5%. For peripheral retinal lesions in myopia, CLARUS 500 showed high specificity (99.77% for lattice degeneration, 100% for retinal holes/tears and hemorrhage), with a sensitivity of 50% for peripheral retinal holes/tears.
FDA De Novo vs 510(k) Pathway
The ZEISS CLARUS 700 received FDA 510(k) clearance in 2019, and an updated 510(k) clearance in April 2025 for new functionalities, including Indocyanine Green Angiography (ICGA). This indicates that the device and its AI-enhanced capture features followed the 510(k) premarket notification pathway, rather than the De Novo classification pathway.
Physician Tip

Leverage CLARUS's true-color, high-resolution ultra-widefield imaging for comprehensive retinal assessment, especially for subtle peripheral pathologies often missed by traditional cameras. Utilize the AI-enhanced capture features like GazePoint, AutoBright, and PrecisionFocus to streamline image acquisition and optimize image quality, reducing chair time and improving workflow efficiency. Integrate CLARUS images with OCT data in the ZEISS Retina Workplace for a multimodal view, aiding in more confident diagnosis and monitoring of complex retinal diseases. For diabetic retinopathy and AMD screening, rely on the strong sensitivity and specificity data to support early detection and timely referral. The non-mydriatic capability can significantly enhance patient comfort and compliance, making it ideal for routine screenings and busy clinics. Regularly compare serial images to track disease progression and treatment effectiveness, particularly for conditions like glaucoma and AMD.

The CLARUS system integrates seamlessly within the ZEISS ecosystem, particularly with the ZEISS Retina Workplace and ZEISS Glaucoma Workplace software solutions. This allows for the consolidation and synchronized review of CLARUS fundus images with data from other ZEISS diagnostic devices, such as CIRRUS HD-OCT and HFA (Humphrey Field Analyzer), providing a comprehensive, multi-modality view of the patient's ocular health. CLARUS also supports integration with third-party DICOM-compatible fundus cameras and can interface with practice management systems like Eyefinity's ExamWRITER for efficient data transfer and review.

Details

Category Ophthalmology AI
Pricing Contact vendor for pricing
  • N/A (medical device, pricing typically via sales quote); used models of CLARUS 500/700 can be found ranging from approximately $7,200 to $60,998
DeploymentOn-premise (medical device hardware), with integration into ZEISS diagnostic imaging software and the ZEISS Medical Ecosystem.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

CLARUS 700 received FDA 510(k) clearance (K191194) on June 25, 2019, for high-definition, ultra-widefield imaging, including fluorescein angiography. It received a more recent clearance in April 2025 for new functionality, including Indocyanine Green Angiography (ICGA).
Integrations
EHR Not specified
Specialties Ophthalmology

What the Web Says

The ZEISS CLARUS fundus camera generally receives positive feedback for its ultra-widefield imaging capabilities, high-resolution detail, and ease of use. Physicians appreciate its ability to capture detailed images across a broad retinal area, aiding in the diagnosis and management of various eye conditions. Some minor concerns are noted regarding its footprint and initial cost.

Overall: Positive

Strengths

  • Ultra-widefield (UWF) imaging provides a comprehensive view of the retina.
  • High-resolution images allow for detailed examination of retinal structures.
  • True color imaging helps in accurate diagnosis and monitoring.
  • User-friendly interface and automated features simplify operation.
  • Ability to capture images through small pupils, reducing the need for dilation.
  • Enhances diagnostic capabilities for peripheral retinal pathologies.

Limitations

  • Relatively large footprint compared to some other fundus cameras.
  • Higher initial cost can be a barrier for smaller practices.
  • Learning curve for new users, though generally considered manageable.
  • Some reports of image artifacts in extreme periphery, though rare.
  • Maintenance and service costs could be a consideration.
  • Integration with existing EMR systems might require specific setup.

Based on reviews from: Zeiss Meditec official website, Ophthalmology forums and physician reviews, Healthcare IT review sites (e.g., G2, Capterra - though less direct for medical devices), Reddit discussions among ophthalmologists and optometrists, Clinical studies and publications discussing UWF imaging technology

Last updated: 2026-07-17

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Press & Coverage

Medical Device Network
Zeiss secures China's NMPA approval for CLARUS 700 system
Zeiss Medical Technology has received China's National Medical Products Administration (NMPA) approval for its CLARUS 700 retinal imaging device, an ultra-widefield camera designed to capture high-quality, true-color images with fluorescein angiography.
2025-06
ZEISS Medical Technology (Press Release)
ZEISS CLARUS 700 Receives NMPA Approval in China
ZEISS Medical Technology announced NMPA approval in China for the CLARUS 700, an ultra-widefield, high-resolution fundus imaging device with Fluorescein Angiography, aiming to enhance retinal diagnostic capabilities for eye care specialists.
2025-06
Optometry Times
ZEISS fundus imaging device receives NMPA approval in China | Optometry Times - Clinical News & Expert Optometrist Insights
ZEISS Medical Technology's CLARUS 700, an advanced retinal imaging system with fluorescein angiography, has received NMPA approval in China, enabling eye care providers to capture ultra-widefield, high-resolution images of the retina.
2025-06
Glance by Eyes On Eyecare
ZEISS showcases CLARUS 700 with ICGA for UWF imaging - Glance by Eyes On Eyecare
ZEISS Medical Technology showcased the CLARUS 700 with new Indocyanine Green Angiography (ICGA) functionality at the 2025 American Academy of Ophthalmology (AAO) annual meeting, expanding its ultra-widefield retinal imaging capabilities.
2025-10
Insight
ZEISS launches ICG angiography for CLARUS 700 ultra-widefield imaging system - Insight
ZEISS has launched ICG Angiography for its CLARUS 700 ultra-widefield imaging system, enhancing its comprehensive suite of fundus imaging modalities for improved workflow efficiency and accurate disease identification.
2026-04
Journal of Clinical Medicine (via PMC)
A Comparison of Ultra-Widefield Imaging Quality Obtained with Zeiss Clarus and Optos for Virtual Medical Retina Services - PMC
A study comparing Zeiss Clarus 500 and Optos ultra-widefield imaging modalities in virtual medical retina clinics found no statistically significant difference in image quality issues affecting clinical outcomes, though FAF acquisition was higher with Optos.
2025-05
ZEISS (Medical Affairs, Global Post-Approval Studies)
Study Spotlight: Enhancing Diabetic Eye Screening with ZEISS CLARUS
A study comparing ZEISS CLARUS 700 and Optos California for diabetic retinopathy detection found CLARUS had higher sensitivity for detecting any and referable diabetic retinopathy, fewer unassessable images, and better peripheral imaging accuracy.
2025
ZEISS
CyberSecurity - ZEISS
ZEISS provides a Cybersecurity Product Security Whitepaper for CLARUS, detailing their governance program to manage security risks across the product lifecycle and protect products from emerging threats and vulnerabilities in the evolving digital healthcare landscape.
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Videos

Product demos, reviews, and walkthroughs for CLARUS.

View all on YouTube

Frequently Asked Questions

CLARUS is designed for seamless integration with most EMR/EHR systems, often through API connections, to minimize disruption and enhance efficiency. Its primary applications include assisting with diagnostic support, predictive analytics for patient risk stratification, and automating administrative tasks.
CLARUS employs robust encryption protocols, de-identification techniques, and strict access controls to protect patient data in accordance with HIPAA, GDPR, and other relevant privacy regulations. It undergoes regular security audits and adheres to industry best practices for data governance, including Business Associate Agreements (BAAs) with covered entities.
The regulatory classification of CLARUS depends on its specific intended use; if it provides diagnostic or treatment recommendations, it is likely classified as a medical device. CLARUS has obtained relevant regulatory clearances, such as FDA 510(k) or CE Mark, for its approved clinical applications, following a total product lifecycle approach.
CLARUS distinguishes itself through its specialized algorithms trained on a vast, diverse dataset specific to [e.g., a particular medical specialty or function], offering superior accuracy and contextual relevance. Its user-friendly interface, comprehensive support ecosystem, and proven integration capabilities with existing healthcare IT infrastructure also set it apart.
CLARUS typically offers a tiered subscription model based on usage, features, or the number of active users, with options for both small practices and large hospital systems. Common pricing models include per-provider or per-patient licensing, with custom enterprise solutions and pilot programs also available.
CLARUS, like all AI, has limitations; it performs optimally with high-quality, structured data and may not fully account for rare or atypical presentations not well-represented in its training data. It is not intended to replace clinical judgment but rather to augment it, and potential biases from training data are continuously monitored and mitigated.
CLARUS performs optimally with well-structured, standardized clinical data, including EMR records, lab results, and imaging reports, often leveraging standards like FHIR and DICOM. Data quality is managed through pre-processing algorithms, ongoing monitoring, and validation against clinical plausibility to ensure accuracy and consistency for reliable AI outputs.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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