# K180393: AIRO Computed Tomography (CT) X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Mobius Imaging, LLC
- Decided: Mar 15, 2018 after 30 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K944131 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160126: AIRO Computed Tomography (CT) X-ray System, Mobius Imaging (2016) Summary page 4.

## Recalls of this device
- Dec 4, 2025 · Class II · Z-1040-2026: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Dec 4, 2025 · Class II · Z-1041-2026: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Dec 7, 2022 · Class II · Z-0957-2023: Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for use
- Nov 18, 2022 · Class II · Z-0344-2023: Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypas
- Aug 1, 2018 · Class II · Z-2991-2018: The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed

## 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 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/K180393
Methodology: https://510kreport.com/methodology