# K173664: Medtronic O-arm O2 Imaging System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Dec 29, 2017 after 30 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: 6 generations back to K003266 (2000). 8 ancestors in all.
14 later devices descend from it; 1 cites it directly.
2 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151000: O-Arm O2 Imaging System, Medtronic, Inc. (2015) Summary page 4.

## Most influential descendants
- K200074: O-arm O2 Imaging System (2020), 13 descendants of its own
- K210912: Excelsius3D (2021), 10 descendants of its own
- K211616: ExcelsiusHub (2021), 9 descendants of its own
- K231850: QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (2024), 2 descendants of its own
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own

## Recalls of this device
- Nov 15, 2019 · Class II · Z-0767-2020: Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher fr
- Sep 17, 2018 · Class II · Z-0404-2019: O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circ

## Indications for use
The O-arm O2 Imaging System is a mobile x-ray system, designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, 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/K173664
Methodology: https://510kreport.com/methodology