# K160126: AIRO Computed Tomography (CT) X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Mobius Imaging
- Decided: Apr 19, 2016 after 90 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K944131 (1995). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131431: Airo CT System, Mobius Imaging, LLC (2013) Summary page 4.

## Most influential descendants
- K180393: AIRO Computed Tomography (CT) X-ray System (2018), 0 descendants of its own

## Recalls of this device
- Sep 26, 2017 · Class II · Z-0715-2018: If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup o
- Jul 28, 2017 · Class II · Z-0509-2018: Risk of unintended motion while the AIRO system is in transport mode.

## Indications for use
The AIRO® is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs (182 kg). Contraindications: Airo is contraindicated as the principal means of guidance during invasive procedures when real-time imaging is needed (e.g., CT Fluoroscopy procedures). In addition, the physician must verify navigation accuracy using an adequate verification method when used with Navigation Systems during surgical procedures.

Source page: https://510kreport.com/device/K160126
Methodology: https://510kreport.com/methodology