Mobius Imaging, LLC

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1041-2026Class IIDetachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.December 4, 2025
Z-1040-2026Class IIDetachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.December 4, 2025
Z-0957-2023Class IIMobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.December 7, 2022
Z-0344-2023Class IIMobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, softwaNovember 18, 2022
Z-2991-2018Class IIAIRO Mobile CT System Model # MobiCT-32August 1, 2018
Z-0715-2018Class IIAIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used fSeptember 26, 2017
Z-1016-2015Class IIAiro Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.December 8, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K180393AIRO Computed Tomography (CT) X-ray SystemMarch 15, 2018
K160126AIRO Computed Tomography (CT) X-ray SystemApril 19, 2016
K131431AIRO CT SYSTEMSeptember 26, 2013