Shirley, MA. (April 24, 2018) – Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo® Mobile CT Imaging System for pediatric applications. The Airo Mobile CT Imaging System previously received 510(k) clearance in 2013 for non-pediatric imaging and has become a market leader in intraoperative, image guided procedures in neuro-spine surgery. Airo diagnostic images also continue to be utilized for supporting applications in brachytherapy, radiation therapy and surgical imaging.
Ayer, Mass. (December 10, 2013) – Mobius Imaging®, LLC, announced today that it has received ISO 13485 Certification for its quality management system. This achievement represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It demonstrates a commitment from management for quality throughout the product development lifecycle and the product’s lifespan with customers.
Airo Size and Flexibility Suitable for Wide Range of Intraoperative Imaging Options
Chicago, Illinois, October 9, 2013 – Brainlab, a leading software technology company with a longstanding dedication to innovation in the fields of neuro- and spinal surgery, announced today the 510(k) clearance from the US Food and Drug Administration (FDA) to market Airo® Mobile Intraoperative CT in the US. The FDA clearance was received by Mobius Imaging®, LLC the developer and manufacturer of Airo Mobile Intraoperative CT on September 26, 2013.