510(k) · Cleared
Recalled · Class II · 2025Oec (R) 9800, Oec (R) 9800 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 4, 2011 as substantially equivalent to K082781 (Ge Healthcare Surgery, 2009) after a 123-day review. Its family tree reaches back 4 generations to 2002. 2 of the 18 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 9 times.
- Decided
- Oct 4, 2011
- Review
- 123 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021049 (2002). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly. 2 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 3 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 2 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 1 generation backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- This deviceK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK132027 Oec 9800 PlusGe Oec Medical Systems, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 4 of its ownK183109 ControlRad Trace Model 8Controlrad, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK123603 Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715…Ge Healthcare Surgery GE Oec Medical Systems, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 3 of its ownK200663 ControlRad Trace Model 9Controlrad, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK172700 OEC OneGe Hualun Medical Systems Co., Ltd. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K132027Oec 9800 PlusGe Oec Medical Systems, Inc. · 2014 · cites it directly6descendants
- K183109ControlRad Trace Model 8Controlrad, Inc. · 2019 · 2 generations on4descendants
- K123603Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 PrimeGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2013 · cites it directly4descendants
- K200663ControlRad Trace Model 9Controlrad, Inc. · 2020 · 3 generations on3descendants
- K172700OEC OneGe Hualun Medical Systems Co., Ltd. · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −3 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −2 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −1 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| 0 (this device) | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | — |
| +1 | K132027 | Oec 9800 Plus | Ge Oec Medical Systems, Inc. | 2014 | 8 |
| +2 | K183109 | ControlRad Trace Model 8 | Controlrad, Inc. | 2019 | — |
| +1 | K123603 | Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013 | 5 |
| +3 | K200663 | ControlRad Trace Model 9 | Controlrad, Inc. | 2020 | — |
| +2 | K172700 | OEC One | Ge Hualun Medical Systems Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K082781 | Oec 9900 EliteSummary page 1…2.1650 and 892.1720 (either) Image-intensified fluoroscopic X- Predicate Device: Device Description: Ray system and Mobile X-Ray system. Product Code: 90JAA and 90IZL. K082781 OEC® 9900 Elite The Series OEC® 9800 is a System used to assist trained Physicians. The system is used to provide X-Ray images w… | 2009 |
What descends from it? (12)
See all 122 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 |
|---|---|---|---|---|
| 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… |
| May 8, 2020 | Class II | Z-2872-2020 | Radiation Control for Health and Safety Act | GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE) change the dose value on the live… |
| Dec 27, 2016 | Class II | Z-1059-2017 | Packaging change control | GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenance and component replacement… |
| Dec 19, 2016 | Class II | Z-0973-2017 | 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. |
| 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. |
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.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K132027 (Ge Oec Medical Systems, Inc., 2014) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K082781.
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. 2011, this device’s year, is highlighted.
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 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
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/K111551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111551: Oec (R) 9800, Oec (R) 9800 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111551
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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