510(k) K131431

AIRO CT SYSTEM by Mobius Imaging, LLC — Product Code JAK

K131431 is an FDA 510(k) premarket notification submitted by Mobius Imaging, LLC for the device "AIRO CT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 2013. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Mobius Imaging, LLC has at least 2 other 510(k) clearances on record.