# K240465: O-arm O2 Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jun 21, 2024 after 126 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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: 8 generations back to K003266 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200074: O-arm O2 Imaging System, Medtronic, Inc. (2020) Summary page 4.

## Recalls of this device
- May 19, 2026 · Class II · Z-2451-2026: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
- May 27, 2025 · Class II · Z-2101-2025: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.

## Indications for use
The O-arm™ O2 Imaging System is a mobile x-ray system, designed for 2D and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm™ O2 Imaging System is compatible with certain image guided surgery systems.

Source page: https://510kreport.com/device/K240465
Methodology: https://510kreport.com/methodology