510(k) · Cleared
Recalled · Class II · 2026O-arm O2 Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 21, 2024 as substantially equivalent to K200074 (Medtronic, Inc., 2020) after a 126-day review. Its family tree reaches back 8 generations to 2000. 1 of the 11 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times.
- Decided
- Jun 21, 2024
- Review
- 126 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003266 (2000). 10 ancestors in all. No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 7 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 6 generations backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- 5 generations backK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- 4 generations backK092564 O-Arm Imaging SystemMedtronic Navigation, Inc. (Littleton) · 2010 · Recalled
- 3 generations backK151000 O-Arm O2 Imaging SystemMedtronic, Inc. · 2015 · Recalled
- 2 generations backK173664 Medtronic O-arm O2 Imaging SystemMedtronic, Inc. · 2017 · Recalled
- 1 generation backK200074 O-arm O2 Imaging SystemMedtronic, Inc. · 2020
- This deviceK240465 O-arm O2 Imaging SystemMedtronic Navigation, Inc. · 2024
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System7 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −7 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −6 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| −5 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| −4 | K092564 | O-Arm Imaging System | Medtronic Navigation, Inc. (Littleton) | 2010 | 18 |
| −3 | K151000 | O-Arm O2 Imaging System | Medtronic, Inc. | 2015 | 7 |
| −2 | K173664 | Medtronic O-arm O2 Imaging System | Medtronic, Inc. | 2017 | 2 |
| −1 | K200074 | O-arm O2 Imaging System | Medtronic, Inc. | 2020 | — |
| 0 (this device) | K240465 | O-arm O2 Imaging System | Medtronic Navigation, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 1 |
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.
1 device in this family has 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 |
|---|---|---|---|
| * | K200074 | O-arm O2 Imaging SystemSummary page 4…Intensified Fluoroscopic X-ray System IV. Device Classification: Class II V. Product Code: Primary - OWB Secondary - OXO, JAA VI. Predicate Device: K200074 – O-arm™ O2 Imaging System 4.2.0 software VII. Product Description: The O-arm™ O2 Imaging System is a mobile x-ray system that p… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2026 | Class II | Z-2451-2026 | Under Investigation by firm | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. |
| May 27, 2025 | Class II | Z-2101-2025 | Under Investigation by firm | A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. |
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.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K200074.
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. 2024, 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 and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16 cm, 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/K240465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240465: O-arm O2 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/K240465
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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