# K092564: O-Arm Imaging System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medtronic Navigation, Inc. (Littleton)
- Decided: Jun 17, 2010 after 301 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003266 (2000). 6 ancestors in all.
16 later devices descend from it; 2 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)
- K050996: O-Arm Imaging System, Breakaway Imaging, LLC (2005) Summary page 1.
- K060344: O-Arm Imaging System, Breakaway Imaging, LLC (2006) Summary page 1.

## Most influential descendants
- K151000: O-Arm O2 Imaging System (2015), 15 descendants of its own
- 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

## Recalls of this device
- May 1, 2019 · Class II · Z-1932-2019: The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of t
- Aug 30, 2018 · Class II · Z-0271-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0273-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0280-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0275-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0277-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0272-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0278-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0279-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0274-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Aug 30, 2018 · Class II · Z-0276-2019: Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, a
- Jan 25, 2018 · Class II · Z-0928-2018: Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inability to power the system after shutdown, System stays in standalone mode, Image reconstruction, System/Pe
- Mar 17, 2016 · Class II · Z-2082-2016: It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
- Jul 25, 2013 · Class II · Z-0973-2014: Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for i
- Jan 31, 2013 · Class II · Z-0926-2013: Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
- Jul 11, 2012 · Class II · Z-2244-2012: A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.
- Oct 15, 2010 · Not classified · Z-0447-2011: Safety Notice: Door Cable Periodic Maintenance Schedule and Cable Wear for the O-ARM Imaging System Breakage of the door cable during opening and closing may occur and cause physical harm or delay of 
- Oct 12, 2010 · Class II · Z-1849-2012: Software Version 3.1.1 does not meet navigational accuracy.

## Indications for use
The O-arm® Imaging System is a portable x-ray system designed for 2D fluoroscopic and 3D imaging for high contrast objects and anatomic structures. The O-arm® Imaging System is compatible with certain Image Guided Surgery Systems. The O-arm® Imaging System may be used with medical charged particle radiation therapy systems for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.

Source page: https://510kreport.com/device/K092564
Methodology: https://510kreport.com/methodology