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 Mar 29, 2006 as substantially equivalent to K050996 (Breakaway Imaging, LLC, 2005) after a 47-day review. Its family tree reaches back 3 generations to 2000. 2 of the 57 devices in its family, counting itself, have a Class I recall. 51 later devices descend from it. It has been recalled once.
- Decided
- Mar 29, 2006
- Review
- 47 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003266 (2000). 5 ancestors in all. 51 later devices descend from it, 2 citing it directly. 2 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 2 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 1 generation backK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- This deviceK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006
- 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
- Descendant · 5 generations on · 21 of its ownK140167 Renaissance X SystemMazor Robotics, Ltd. · 2014
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 51 · See all- 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
- K140167Renaissance X SystemMazor Robotics, Ltd. · 2014 · 5 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −2 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −1 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| 0 (this device) | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | — |
| +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 | — |
| +5 | K140167 | Renaissance X System | Mazor Robotics, Ltd. | 2014 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K050996 | O-Arm Imaging SystemSummary page 1…bstantial Equivalence The O-arm™ Imaging System with the 1-D Display Control Mouse is substantially equivalent to the O-arm™ Imaging System, which was cleared in 510(k) K050996. The display control functions provided by the optional sterile disposable wireless 1-D Control Mouse are also provided by conso… | 2005 |
What descends from it? (51)
See all 512 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. |
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 6 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K081672 (Mazor Surgical Technologies, Ltd., 2008) has gone furthest, with 33 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.
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/K060344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060344: O-Arm 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/K060344
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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