Candelis Diagnostic Radiology Viewer Receives FDA 510(k) Clearance

Candelis, Inc. has obtained FDA 510(k) clearance for its ImageGrid StreamVue Enterprise platform, enabling the company to market and sell its streaming-based software in the United States. The clearance marks a significant step for the company in the healthcare technology sector.

The ImageGrid StreamVue Enterprise platform functions as a diagnostic radiology viewer, built to operate on a healthcare facility's existing PACS (Picture Archiving and Communication System) infrastructure. This approach allows medical institutions to access and view radiological images efficiently without requiring extensive hardware overhauls.

The FDA's 510(k) clearance is a regulatory process that demonstrates a medical device is substantially equivalent in safety and performance to an already marketed device. Obtaining this clearance indicates that Candelis's platform meets the necessary federal standards for such medical software.

Based in Newport Beach, California, Candelis focuses on providing software solutions for radiological imaging. This FDA approval is expected to facilitate the company's growth and adoption within the U.S. healthcare market.