ZEISS CLINIC 360 receives FDA 510k clearance

ZEISS Medical Technology, one of the world's leading medical technology companies, today announced the 510k clearance from the U.S. Food and Drug Administration (FDA) for ZEISS CLINIC 3601. An all-in-one cloud and browser-based software solution, ZEISS CLINIC 360 combines diagnostic and medical data into a comprehensive patient view. By making relevant information easy to access and review, the solution helps clinicians evaluate disease progression, support treatment decisions, and improve workflow efficiency. ZEISS CLINIC 360 is part of the ZEISS ophthalmic workflow portfolio and will be available in the U.S. in early Fall 2026.

Create a comprehensive patient overview
Combining information from diagnostic devices, electronic medical records, and practice systems, ZEISS CLINIC 360 creates a comprehensive patient record that allows clinicians to view their DICOM-enabled diagnostic device data – including CIRRUS®, CLARUS® and HFA® from ZEISS, as well as third-party devices – to gain a unified, multi-modality view, enabling faster, more informed decisions to deliver high-quality, personalized care. ZEISS CLINIC 360 includes EMR integration2 that seamlessly consolidates critical patient data – including risk factors, family history, allergies, and more – into the clinical workflow, organizing medical and diagnostic data together to present a comprehensive view of the patient's condition.

Gain actionable clinical insights
Leveraging disease-based summaries, interactive analysis, and collaboration tools, ZEISS CLINIC 360 transforms data into actionable clinical insights to enhance patient care. Clinicians can quickly monitor glaucoma progression, for example, with intuitive color-coded alerts and trend analysis of OCT, IOP and Visual Field data. ZEISS CLINIC 360 streamlines the clinical workflow with automated, interactive tools and analyses, providing greater efficiency across the workflow. When consultation is needed, clinicians can securely share cases and reports and request input from colleagues through integrated access to the ZEISS Collaborative Care feature, helping to facilitate improved patient care and referrals.

Designed for different clinical practice models
Built on the ZEISS Health Data Platform, ZEISS CLINIC 360 is accessed through the cloud or a web-based browser, enabling clinicians to review information across locations without requiring local software installation. Subscription options allow practices to select the configuration that best aligns with their operational and clinical requirements.

More information can be found here.