510(k) · Cleared
Recalled · 2010O-Arm Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breakaway Imaging, LLC · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on May 5, 2005 as substantially equivalent to K032280 (Siemens AG, 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 2000. 2 of the 57 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it. It has been recalled 4 times.
- Decided
- May 5, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003266 (2000). 4 ancestors in all. 52 later devices descend from it, 3 citing it directly. 2 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 1 generation backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- This deviceK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005
- Descendant · cites it directly · 51 of its ownK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- Descendant · cites it directly · 33 of its ownK081672 C-InsightMazor Surgical Technologies, Ltd. · 2008
- Descendant · 2 generations on · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- Descendant · 3 generations on · 24 of its ownK110911 Renaissance SystemMazor Robotics, Ltd. · 2011
- Descendant · 4 generations on · 23 of its ownK113228 Renaissance SystemMazor Robotics, Ltd. · 2011
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 52 · See all- K060344O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · cites it directly51descendants
- K081672C-InsightMazor Surgical Technologies, Ltd. · 2008 · cites it directly33descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 2 generations on31descendants
- K110911Renaissance SystemMazor Robotics, Ltd. · 2011 · 3 generations on24descendants
- K113228Renaissance SystemMazor Robotics, Ltd. · 2011 · 4 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −1 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| 0 (this device) | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | — |
| +1 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| +1 | K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| +3 | K110911 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
| +4 | K113228 | Renaissance System | Mazor Robotics, Ltd. | 2011 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 1 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 8 | 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 |
|---|---|---|---|
| * | K032280 | Siremobil Iso-C 3DSummary page 1…11 Product Codes: o) (o) Substantial Equivalence The O-Arm™ Imaging System is substantially equivalent to the Siemens SIREMOBIL Is0-C*°, which was cleared in 510(k)’s K032280 and K003266. Device Description _ The O-Arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D flu… | 2003 |
| * | K003266 | Siremobil Iso-C 3DSummary page 1…Codes: o) (o) Substantial Equivalence The O-Arm™ Imaging System is substantially equivalent to the Siemens SIREMOBIL Is0-C*°, which was cleared in 510(k)’s K032280 and K003266. Device Description _ The O-Arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic im… | 2000 |
What descends from it? (52)
See all 523 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 10, 2010 | Not classified | Z-1998-2010 | Device Design | The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy. |
| Jun 30, 2008 | Not classified | Z-2034-2008 | Radiation Control for Health and Safety Act | Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii) |
| Nov 27, 2007 | Not classified | Z-0624-2009 | Software design | Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker. |
| Oct 17, 2007 | Not classified | Z-0294-2008 | Software change control | Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the… |
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 5 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K060344 (Breakaway Imaging, LLC, 2006) has gone furthest, with 51 descendants of its own.
- 2 other devices also cite its predicate K032280.
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.
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 designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgical Systems.
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/K050996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050996: O-Arm Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050996
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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