Candelis Receives FDA 510(k) Clearance for Diagnostic Imaging Viewer
The U.S. Food and Drug Administration (FDA) has granted Candelis 510(k) clearance for ImageGrid StreamVue, an enterprise diagnostic streaming viewer for medical imaging.
New York – Candelis announced on July 30, 2026, that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its ImageGrid StreamVue software. The program allows for the streaming of diagnostic medical images within enterprise environments.
This clearance represents a significant step for the medical imaging solutions provider, paving the way for the software's commercial deployment in the U.S. market. ImageGrid StreamVue is designed to deliver diagnostic imaging performance from any location, aiming to bypass the costs and disruptions associated with traditional enterprise viewing platforms.
Candelis, specializing in radiology and imaging software solutions, intends for this product to address the growing need among healthcare providers for flexible and cost-effective ways to access patient data. The FDA's 510(k) clearance signifies that the software meets the same safety and effectiveness standards required for predicate devices already on the market.
With the clearance secured, the company is expected to focus on marketing and distributing the software across North America, aiming to equip healthcare professionals with more efficient diagnostic tools.