510(k) · Cleared
Recalled · Class I · 2025Oec 9800 Plus 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 · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 17, 2002 after a 16-day review. The FDA summary names its predicate without a number. 1 of the 77 devices in its family, counting itself, has a Class I recall. 76 later devices descend from it. It has been recalled 26 times, including a Class I recall.
- Decided
- Apr 17, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 26 (1 Class I)
- Predicates
- 0
76 later devices descend from it, 6 citing it directly. 1 of the 77 devices in this family, counting this one, has a Class I recall.
- This deviceK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002
- Descendant · cites it directly · 40 of its ownK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 38 of its ownK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- Descendant · 2 generations on · 35 of its ownK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- Descendant · 3 generations on · 18 of its ownK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- Descendant · cites it directly · 18 of its ownK061203 Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · Recalled
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K041932Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · cites it directly40descendants
- K073543Oec 9900 EliteGe Oec Medical Systems · 2008 · 2 generations on38descendants
- K082781Oec 9900 EliteGe Healthcare Surgery · 2009 · 2 generations on35descendants
- K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · 3 generations on18descendants
- K061203Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · cites it directly18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | — |
| +1 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| +2 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| +2 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| +3 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| +1 | K061203 | Ziehm Vision R Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 3 | 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 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 |
|---|---|---|---|
| * | — | OEC 9800 Digital Mobile Imaging System Named without a submission number |
What descends from it? (76)
See all 766 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2025 | Class II | Z-2341-2025 | Radiation Control for Health and Safety Act | GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will… |
| Nov 21, 2024 | Class II | Z-0706-2025 | Process control | Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. |
| 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-2276-2023 | 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… |
| Jul 22, 2016 | Class II | Z-2629-2016 | Software design (manufacturing process) | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. |
| Oct 3, 2014 | Class II | Z-0195-2015 | 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. |
| Apr 26, 2010 | Class II | Z-2241-2012 | Component change control | GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. |
| Nov 6, 2009 | Class II | Z-2240-2012 | Device Design | GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing… |
| Oct 10, 2008 | Class II | Z-2262-2012 | Device Design | GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. |
| Aug 29, 2008 | Not classified | Z-1730-2009 | Release of Material/Component prior to receiving test results | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in… |
| Aug 15, 2008 | Not classified | Z-1706-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1708-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1707-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1709-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Apr 15, 2008 | Not classified | Z-1705-2008 | Device Design | Use of existing four-pedal footswitch on a different machine may cause various operational errors. |
| Feb 22, 2008 | Class I | Z-2038-2012 | 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. The vertical lift column power supply in the mainframe C-arm of the device is… |
| Nov 19, 2007 | Class II | Z-2026-2012 | 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… |
| Mar 27, 2007 | Class II | Z-2125-2012 | 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… |
| Mar 1, 2007 | Not classified | Z-0681-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0680-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0677-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0682-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Feb 9, 2007 | Not classified | Z-0557-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0556-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0558-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0559-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
The 5 latest of 26 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041932 (Ge Oec Medical Systems, Inc., 2004) has gone furthest, with 40 descendants of its own.
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.
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 OEC 9800 Plus Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.
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/K021049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021049: Oec 9800 Plus Digital Mobile 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/K021049
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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