510(k) · Cleared
Recalled · Class II · 2024O-Arm O2 Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 6, 2015 as substantially equivalent to K092564 (Medtronic Navigation, Inc. (Littleton), 2010) after a 113-day review. Its family tree reaches back 5 generations to 2000. 2 of the 23 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 6, 2015
- Review
- 113 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003266 (2000). 7 ancestors in all. 15 later devices descend from it, 1 citing it directly. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 4 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 3 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- 2 generations backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- 1 generation backK092564 O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 2010 · Recalled
- This deviceK151000 O-Arm O2 Imaging SystemMedtronic, Inc. · 2015
- Descendant · cites it directly · 14 of its ownK173664 Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 13 of its ownK200074 O-arm O2 Imaging SystemMedtronic, Inc. · 2020
- Descendant · 3 generations on · 10 of its ownK210912 Excelsius3DGlobus Medical, Inc. · 2021
- Descendant · 4 generations on · 9 of its ownK211616 ExcelsiusHubGlobus Medical, Inc. · 2021 · Recalled (Class I)
- Descendant · 5 generations on · 2 of its ownK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 15 · See all- K173664Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · cites it directly14descendants
- K200074O-arm O2 Imaging SystemMedtronic, Inc. · 2020 · 2 generations on13descendants
- K210912Excelsius3DGlobus Medical, Inc. · 2021 · 3 generations on10descendants
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on9descendants
- K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −4 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −3 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| −2 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| −1 | K092564 | O-Arm Imaging System | Medtronic Navigation, Inc. (Littleton) | 2010 | 18 |
| 0 (this device) | K151000 | O-Arm O2 Imaging System | Medtronic, Inc. | 2015 | — |
| +1 | K173664 | Medtronic O-arm O2 Imaging System | Medtronic, Inc. | 2017 | 2 |
| +2 | K200074 | O-arm O2 Imaging System | Medtronic, Inc. | 2020 | — |
| +3 | K210912 | Excelsius3D | Globus Medical, Inc. | 2021 | — |
| +4 | K211616 | ExcelsiusHub | Globus Medical, Inc. | 2021 | Class I |
| +5 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | — |
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 |
|---|---|---|
| 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K092564 | O-Arm Imaging SystemSummary page 4…Secondary: OXO, JAA Classification Name: 892.1650 - Image Intensified Fluoroscopic X-ray System, Mobile Predicate Device: K092564 – Medtronic O-arm® Imaging System Device Description: The O-arm® O2 Imaging System is a mobile x-ray system that provid… | 2010 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173664 | Medtronic O-arm O2 Imaging System | 2017 | 14 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 26, 2024 | Class II | Z-2026-2024 | Device Design | 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 of surgery, or completion of surgery… |
| Jul 25, 2023 | Class II | Z-2449-2023 | Under Investigation by firm | Ground cable installed incorrectly. |
| Nov 15, 2019 | Class II | Z-0767-2020 | Device Design | 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 frequency in these systems. If the belt… |
| Sep 30, 2017 | Class II | Z-0927-2018 | Employee error | 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 disconnecting/reconnecting process which may… |
| Sep 22, 2016 | Class II | Z-0070-2017 | Software design | O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images |
| Mar 17, 2016 | Class II | Z-2083-2016 | Radiation Control for Health and Safety Act | 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 provided to users in 21CFR part 1 020.30(h). |
| Jan 29, 2016 | Class II | Z-1088-2016 | Process control | 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 during 3D Imaging could lead to poor image… |
The 5 latest of 7 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 15 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173664 (Medtronic, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K092564.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151000 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151000: O-Arm O2 Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151000
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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