Aug. 1, 2026 — Candelis recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for ImageGrid StreamVue, the company's next-generation enterprise imaging and diagnostic viewing platform.
StreamVue provides radiologists and physicians with fast, intuitive access to diagnostic-quality images across multiple imaging modalities while offering healthcare organizations unprecedented flexibility in deployment and integration.
Powered by Candelis' proprietary image streaming technology, ImageGrid StreamVue rapidly delivers diagnostic-quality images to clinicians wherever they are working, whether inside the hospital, at an imaging center, or reading remotely. By intelligently streaming only the image data needed for immediate review, StreamVue minimizes latency and enables secure, fast loading and navigation of large imaging studies across CT, MR, ultrasound, digital radiography, mammography, PET, and other DICOM-compliant imaging modalities, even over wide-area networks. StreamVue's quick loading times allow radiologists to move through their images faster, allowing them to dedicate more time to diagnostic accuracy and patient care.
Healthcare organizations can deploy StreamVue in the configuration that best fits their infrastructure and IT strategy. The platform is available as an on-premises hardware appliance, a virtual machine (VM), or a cloud-hosted solution, allowing organizations to modernize imaging workflows without compromising operational requirements. Organizations can deploy StreamVue in days, not months, helping radiologists become productive faster while reducing implementation risk and lowering total cost of ownership.
FDA Clearance
"FDA clearance for StreamVue marks a significant milestone in delivering a faster, more flexible enterprise imaging platform for healthcare providers," said Robert Van Uitert, Vice President of Marketing and Products at Candelis. "For too long, healthcare organizations have had to choose between legacy viewers that slow radiologists down and costly enterprise platforms that can be difficult to justify. StreamVue eliminates this tradeoff by allowing providers to keep their existing PACS, while providing fast and responsive access to diagnostic images whether they are on-site or working remotely. With many deployment options, StreamVue provides healthcare organizations with a practical way to modernize their enterprise imaging with minimal disruption. The platform has also generated strong interest from several of the world's largest OEM healthcare technology companies, which have expressed interest in distributing StreamVue alongside their imaging modalities, further validating its value and market potential."
Built on the proven ImageGrid enterprise imaging architecture, StreamVue combines high-performance diagnostic viewing with streamlined administration, scalable enterprise deployment, and simplified maintenance. Its advanced streaming architecture enables healthcare organizations to support growing imaging volumes while providing a consistent, high-performance diagnostic experience across distributed reading environments, reducing infrastructure complexity and ongoing operational costs.
The FDA 510(k) clearance reinforces Candelis' commitment to delivering innovative enterprise imaging solutions that improve diagnostic efficiency, simplify IT management, and support the evolving needs of hospitals, imaging centers, and healthcare networks.
September 21, 2026 
