510(k) K180393

AIRO Computed Tomography (CT) X-ray System by Mobius Imaging, LLC — Product Code JAK

K180393 is an FDA 510(k) premarket notification submitted by Mobius Imaging, LLC for the device "AIRO Computed Tomography (CT) X-ray System". The FDA issued a decision of Substantially Equivalent on March 15, 2018. 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.