Mobius Imaging LLC announced it has received 510(k) clearance for its Airo Mobile CT Imaging System for pediatric applications, according to a company press release.
In 2013, the imaging system received 510(k) clearance for non-pediatric imaging. Airo diagnostic images are still used in supporting applications for brachytherapy, radiation therapy and surgical imaging.
“There is an unmet need in being able to provide safe and reliable CT imaging for pediatric patients during various clinical procedures” Gene Gregerson, CEO of Mobius Imaging, said in the release. “CT systems must be designed and validated for safety and efficacy using different protocols than would be appropriate for adult patients. We are delighted to now be able to offer the benefits of Airo Mobile CT imaging to clinicians and their pediatric patients.”