510(k) · Cleared
Recalled · Class II · 2019O-Arm Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. (Littleton) · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jun 17, 2010 as substantially equivalent to K050996 (Breakaway Imaging, LLC, 2005) and 1 other predicate after a 301-day review. Its family tree reaches back 4 generations to 2000. 2 of the 23 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it. It has been recalled 18 times.
- Decided
- Jun 17, 2010
- Review
- 301 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 18
- Predicates
- 2
Its longest line of descent runs back 4 generations to K003266 (2000). 6 ancestors in all. 16 later devices descend from it, 2 citing it directly. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 3 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 2 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- 1 generation backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- This deviceK092564 O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 2010
- Descendant · cites it directly · 15 of its ownK151000 O-Arm O2 Imaging SystemMedtronic, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 14 of its ownK173664 Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 13 of its ownK200074 O-arm O2 Imaging SystemMedtronic, Inc. · 2020
- Descendant · cites it directly · 10 of its ownK210912 Excelsius3DGlobus Medical, Inc. · 2021
- Descendant · 2 generations on · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K151000O-Arm O2 Imaging SystemMedtronic, Inc. · 2015 · cites it directly15descendants
- K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · 2 generations on14descendants
- K200074O-arm O2 Imaging SystemMedtronic, Inc. · 2020 · 3 generations on13descendants
- K210912Excelsius3DGlobus Medical, Inc. · 2021 · cites it directly10descendants
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −3 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −2 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| −1 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| 0 (this device) | K092564 | O-Arm Imaging System | Medtronic Navigation, Inc. (Littleton) | 2010 | — |
| +1 | K151000 | O-Arm O2 Imaging System | Medtronic, Inc. | 2015 | 7 |
| +2 | K173664 | Medtronic O-arm O2 Imaging System | Medtronic, Inc. | 2017 | 2 |
| +3 | K200074 | O-arm O2 Imaging System | Medtronic, Inc. | 2020 | — |
| +1 | K210912 | Excelsius3D | Globus Medical, Inc. | 2021 | — |
| +2 | K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 1 |
| 2022 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050996 | O-Arm Imaging SystemSummary page 1…tem Mobile x-ray system Name: System, X-ray, mobile Regulation: 21 CFR 892.1720 Product cddt;{ LH N ¢ o0 O-arm® Imaging System, which was cleared to market in 510(k)s K050996 and K060344, The O-arm® Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. T… | 2005 |
| * | K060344 | O-Arm Imaging SystemSummary page 1…-ray system Name: System, X-ray, mobile Regulation: 21 CFR 892.1720 Product cddt;{ LH N ¢ o0 O-arm® Imaging System, which was cleared to market in 510(k)s K050996 and K060344, The O-arm® Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system co… | 2006 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2019 | Class II | Z-1932-2019 | Device Design | 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 the potential capacity and results in… |
| Aug 30, 2018 | Class II | Z-0271-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0273-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0280-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0275-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0277-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0272-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0278-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0279-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0274-2019 | Software design | 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, and logs generation. Software version… |
| Aug 30, 2018 | Class II | Z-0276-2019 | Software design | 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, and logs generation. Software version… |
| Jan 25, 2018 | Class II | Z-0928-2018 | Software design | 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/Pendant bootup, Dose display/report… |
| Mar 17, 2016 | Class II | Z-2082-2016 | Radiation Control for Health and Safety Act | 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 | Radiation Control for Health and Safety Act | 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 information to be provided to users in… |
| Jan 31, 2013 | Class II | Z-0926-2013 | Component design/selection | 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 | Component change control | 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 | Equipment maintenance | 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 therapy |
| Oct 12, 2010 | Class II | Z-1849-2012 | Software design | Software Version 3.1.1 does not meet navigational accuracy. |
The 5 latest of 18 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K151000 (Medtronic, Inc., 2015) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K050996.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092564 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092564: O-Arm Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092564
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026