# K131431: Airo CT System

- Pathway: 510(k) (Traditional)
- Applicant: Mobius Imaging, LLC
- Decided: Sep 26, 2013 after 132 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K944131 (1995). 25 ancestors in all.
2 later devices descend 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)
- K102677: Bodytom NL 4000, Neurologica Corporation (2011) Summary page 1.

## Most influential descendants
- K160126: AIRO Computed Tomography (CT) X-ray System (2016), 1 descendant of its own
- K180393: AIRO Computed Tomography (CT) X-ray System (2018), 0 descendants of its own

## Recalls of this device
- Dec 8, 2014 · Class II · Z-1016-2015: There is a risk that during the transfer of an image and navigation data to the Brainlab Curve Image Guided Surgery Navigation System after a CT scan, an error may occur, causing either no navigation 

## Indications for use
The AIRO' m is intended to be used for non-contrast 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). Airo is contraindicated as the principal means of guidance during surgical procedures. The physician must verify navigation accuracy using known anatomical landmarks or an equivalent verification method when used in surgical procedures.

Source page: https://510kreport.com/device/K131431
Methodology: https://510kreport.com/methodology