RadUnity has received FDA 510(k) clearance as a Class II Medical Device, the company announced today.

“With this clearance, we’ve made a significant leap toward turning an academic concept into a practical clinical solution,” RadUnity Founder Tim Szczykutowicz said in a statement. “This milestone will help us secure additional funding and expand our team. It brings us closer to fulfilling my goal of providing a solution that the community will embrace and use to improve patient care.”

According to a release, the FDA clearance will help the company’s mission of ensuring consistent formatting and image presentation in computed tomography (CT) scans.

RadUnity addresses the problem of inconsistency in medical imaging by centralizing the management of image creation before radiologists or AI solutions interpret or process the images.

510(k), or premarket notification, is used by companies that intend to introduce a device into commercial distribution for the first time.