510(k) · Cleared
Recalled · Class I · 2023Flexiview 8800 Digital Mobile Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Mar 12, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 87 devices in its family, counting itself, have a Class I recall. 86 later devices descend from it. It has been recalled 9 times, including a Class I recall.
- Decided
- Mar 12, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 9 (1 Class I)
- Predicates
- 0
86 later devices descend from it, 3 citing it directly. 2 of the 87 devices in this family, counting this one, have a Class I recall.
- This deviceK003837 Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001
- Descendant · cites it directly · 83 of its ownK032280 Siremobil Iso-C 3DSiemens AG · 2003
- Descendant · 2 generations on · 52 of its ownK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- Descendant · 3 generations on · 51 of its ownK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- Descendant · 2 generations on · 33 of its ownK081672 C-InsightMazor Surgical Technologies, Ltd. · 2008
- Descendant · 3 generations on · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 86 · See all- K032280Siremobil Iso-C 3DSiemens AG · 2003 · cites it directly83descendants
- K050996O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · 2 generations on52descendants
- K060344O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · 3 generations on51descendants
- K081672C-InsightMazor Surgical Technologies, Ltd. · 2008 · 2 generations on33descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003837 | Flexiview 8800 Digital Mobile Imaging System | Ge Oec Medical Systems | 2001 | — |
| +1 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| +2 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| +3 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| +2 | K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +3 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 1 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 11 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (86)
See all 863 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 15, 2023 | Class II | Z-2279-2023 | Process control | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries… |
| May 15, 2023 | Class II | Z-2275-2023 | Process control | Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries… |
| Feb 21, 2017 | Class II | Z-1469-2017 | Process control | OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures. |
| Oct 3, 2014 | Class II | Z-0194-2015 | Component design/selection | GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems. |
| Nov 19, 2007 | Class II | Z-2027-2012 | Device Design | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of… |
| Oct 19, 2007 | Class II | Z-2221-2012 | Nonconforming Material/Component | X-ray units did not meet manufacturer's specification for linearity. |
| Jun 12, 2007 | Not classified | Z-0850-2007 | Other | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| Mar 1, 2007 | Not classified | Z-0678-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Nov 20, 2006 | Class I | Z-2065-2012 | Device Design | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 8800 Flexview was recalled in November 2006 due to several intermittent… |
The 5 latest of 9 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032280 (Siemens AG, 2003) has gone furthest, with 83 descendants of its own.
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 | — |
https://510kreport.com/device/K003837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003837: Flexiview 8800 Digital Mobile 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/K003837
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026