# K151000: O-Arm O2 Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Aug 6, 2015 after 113 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003266 (2000). 7 ancestors in all.
15 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)
- K092564: O-Arm Imaging System, Medtronic Navigation, Inc. (Littleton) (2010) Summary page 4.

## Most influential descendants
- K173664: Medtronic O-arm O2 Imaging System (2017), 14 descendants of its own
- 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

## Recalls of this device
- Apr 26, 2024 · Class II · Z-2026-2024: Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling o
- Jul 25, 2023 · Class II · Z-2449-2023: Ground cable installed incorrectly.
- 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 30, 2017 · Class II · Z-0927-2018: During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the discon
- Sep 22, 2016 · Class II · Z-0070-2017: O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
- Mar 17, 2016 · Class II · Z-2083-2016: Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provide
- Jan 29, 2016 · Class II · Z-1088-2016: Screws holding the detector panel in as a result the detector panel could make contact with other parts with in the 0-arm¿ 02 Imaging System, causing noise and vibration when being positioned or durin

## 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/K151000
Methodology: https://510kreport.com/methodology