# K200074: O-arm O2 Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Apr 24, 2020 after 101 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003266 (2000). 9 ancestors in all.
13 later devices descend from it; 3 cite 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)
- K173664: Medtronic O-arm O2 Imaging System, Medtronic, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own

## Indications for use
The O-arm O2 Imaging System is a mobile x-ray system designed for 2D and 3D imaging for adults and pediatric patients weighing 60lbs 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 anatomical structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System in compatible with certain image guided surgery systems.

Source page: https://510kreport.com/device/K200074
Methodology: https://510kreport.com/methodology