510(k) · Cleared
Recalled · Class I · 2016Mini 6800 Digital Mobile C-Arm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Dec Medical Systems · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Aug 19, 1999 after a 23-day review. The FDA summary names its predicate without a number. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Aug 19, 1999
- Review
- 23 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 7 (1 Class I)
- Predicates
- 0
2 later devices descend from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK992506 Mini 6800 Digital Mobile C-ArmGe Dec Medical Systems · 1999
- Descendant · cites it directly · 1 of its ownK160131 OEC Elite MiniViewGe Hangwei Medical Systems Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK171800 OEC Elite MiniViewGe Hualun Medical Systems Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992506 | Mini 6800 Digital Mobile C-Arm | Ge Dec Medical Systems | 1999 | — |
| +1 | K160131 | OEC Elite MiniView | Ge Hangwei Medical Systems Co., Ltd. | 2016 | — |
| +2 | K171800 | OEC Elite MiniView | Ge Hualun Medical Systems Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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.
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 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? (3)
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 |
|---|---|---|---|
| * | — | MINI 6600 Digital Mobile C-arm Named without a submission number | |
| * | — | FluoroScan Premier Named without a submission number | |
| * | — | ORCA Orthopedic C-arm Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160131 | OEC Elite MiniView | 2016 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2016 | Class II | Z-0974-2017 | Use error | GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures. |
| Oct 3, 2014 | Class II | Z-0193-2015 | 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. |
| Jun 12, 2007 | Not classified | Z-0851-2007 | Other | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| May 24, 2007 | Not classified | Z-0928-2007 | Other | X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures |
| Mar 27, 2007 | Class II | Z-2126-2012 | Software 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 had discovered an issue with the hard disk drives that were installed on… |
| Nov 20, 2006 | Class I | Z-2040-2012 | 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 6800 Miniview was recalled in November 2006 due to several intermittent… |
| Mar 28, 2006 | Not classified | Z-0704-06 | Other | Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K160131 (Ge Hangwei Medical Systems Co., Ltd., 2016) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The MINI 6800 Digital Mobile C-arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging.
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/K992506 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992506: Mini 6800 Digital Mobile C-Arm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992506
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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