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New Diagnostic Radiology Viewer Achieves FDA 510(k) Clearance, Setting Industry Benchmark


News provided by

Candelis, Inc.

Oct 04, 2026, 11:00 ET

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Candelis, Inc. has earned FDA 510(k) clearance for its ImageGrid StreamVue Enterprise platform, positioning the streaming-based software among the top-rated diagnostic radiology viewer options built to run on a facility's existing PACS infrastructure.

NEWPORT BEACH, Calif., Oct. 4, 2026 /PRNewswire-PRWeb/ -- Healthcare organizations searching for top-rated diagnostic radiology viewers now have a new benchmark to weigh. In July 2026, Candelis, Inc.'s ImageGrid StreamVue Enterprise diagnostic streaming viewer received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

The clearance confirms the platform is fit for diagnostic use across several imaging modalities, arriving as radiologists increasingly demand faster, more flexible access to studies without replacing the archive systems already in place.

What Makes a Diagnostic Radiology Viewer Top-Rated?

Speed and compatibility, more than novelty, typically separate a top-tier platform from the rest of the field. Radiology teams evaluating the best diagnostic radiology viewer software tend to prioritize instant access to full-fidelity images, minimal setup disruption and compatibility with equipment already installed.

StreamVue streams full-fidelity images from a wide range of modalities, including ultrasound, X-ray, CT, MRI and mammography. It prevents lag during remote sessions by efficiently delivering only the image data required for immediate viewing. The platform is browser-based, with no local caching required, allowing radiologists to read from a hospital, an imaging center or a remote location without additional infrastructure.

How Does StreamVue Strengthen Existing PACS Systems?

StreamVue layers directly onto a facility's current PACS rather than replacing it, a distinction that IT teams sifting through radiology DICOM viewer reviews flag as a deciding factor.

Because no migration or rip-and-replace is required, organizations can use the ImageGrid StreamVue Enterprise platform in days rather than months, increasing existing PACS speed while enabling lightning-fast study transfer between authorized users. According to Robert Van Uitert, Vice President of Marketing and Products, "StreamVue eliminates this tradeoff by allowing providers to keep their existing PACS."

The platform also supports simple setup, seamless integration into current workflows and the ability to easily share images across facilities, positioning it among the top PACS viewer software choices for organizations modernizing without disruption. Interested healthcare organizations can request a demo for a personalized walk-through of the platform.

Candelis built StreamVue on more than two decades of enterprise imaging expertise, with technology now used by over 4,000 imaging facilities worldwide. That foundation, combined with the new FDA clearance, gives healthcare organizations a documented, regulatory-backed reason to consider StreamVue as they gradually modernize enterprise imaging, rather than facing a costly, all-or-nothing infrastructure overhaul.

About Candelis, Inc.

Candelis, Inc. develops enterprise imaging and diagnostic viewing technology for healthcare organizations. The company's ImageGrid platform is backed by over two decades of experience in medical imaging infrastructure, with technology deployed across thousands of facilities worldwide. Candelis focuses on solutions that integrate with existing PACS environments, helping healthcare organizations modernize while avoiding disruptive system replacement. ImageGrid StreamVue Enterprise, the company's diagnostic streaming viewer, holds FDA 510(k) clearance for diagnostic use.

Media Contact

Shane Jones, Candelis, Inc., 1 (717) 928-0683, [email protected], https://www.candelis.com/

SOURCE Candelis, Inc.

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