510(k) · Cleared
Recalled · Class II · 2025Oec 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 May 1, 2014 as substantially equivalent to K111551 (Ge Oec Medical Systems, Inc., 2011) after a 304-day review. Its family tree reaches back 5 generations to 2002. 2 of the 13 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 8 times.
- Decided
- May 1, 2014
- Review
- 304 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 5 generations to K021049 (2002). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 4 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 2 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 1 generation backK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- This deviceK132027 Oec 9800 PlusGe Oec Medical Systems, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK183109 ControlRad Trace Model 8Controlrad, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK200663 ControlRad Trace Model 9Controlrad, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK202431 ControlRad Select Model ZControlrad, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK251650 Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK213455 ControlRad Select Model ZControlrad, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K183109ControlRad Trace Model 8Controlrad, Inc. · 2019 · cites it directly4descendants
- K200663ControlRad Trace Model 9Controlrad, Inc. · 2020 · 2 generations on3descendants
- K202431ControlRad Select Model ZControlrad, Inc. · 2020 · 3 generations on2descendants
- K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC · 2025 · cites it directly0descendants
- K213455ControlRad Select Model ZControlrad, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −4 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −3 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −2 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −1 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| 0 (this device) | K132027 | Oec 9800 Plus | Ge Oec Medical Systems, Inc. | 2014 | — |
| +1 | K183109 | ControlRad Trace Model 8 | Controlrad, Inc. | 2019 | — |
| +2 | K200663 | ControlRad Trace Model 9 | Controlrad, Inc. | 2020 | — |
| +3 | K202431 | ControlRad Select Model Z | Controlrad, Inc. | 2020 | — |
| +1 | K251650 | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | 2025 | — |
| +4 | K213455 | ControlRad Select Model Z | Controlrad, Inc. | 2021 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2025 | 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.
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 |
|---|---|---|---|
| * | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | 2011 |
What descends from it? (6)
2 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. |
| 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 8 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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 6 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K183109 (Controlrad, Inc., 2019) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K111551.
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. 2014, 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 QEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography. endoscopic. urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132027: Oec 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/K132027
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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