The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Aikenist Technologies to market its QuickRad AI PACS and RIS with viewer product.
The company described the system as a web-based PACS featuring a "Zero Footprint Viewer" with precision measurement tools, structured reporting, and automated AI-assisted diagnosis. It can be deployed on site, in private cloud environments, or on major cloud platforms, and supports FDA-cleared AI algorithms for oncology, neurology, and cardiology, Aikenist added.
The Bengaluru, India-based firm said FDA clearance of the device allows it to expand into North America. The system is designed for use by proficient and certified medical practitioners, including physicians, radiologists, and medical technicians, according to its indications for use. It offers optional integration with FDA-cleared third-party Al models, enabling the visualization of Al-generated outputs.
