510(k) · Cleared
Recalled · Class II · 2025Oec 9900 Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Surgery GE Oec Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Apr 6, 2012 as substantially equivalent to K082781 (Ge Healthcare Surgery, 2009) after a 37-day review. Its family tree reaches back 4 generations to 2002. 2 of the 24 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 6, 2012
- Review
- 37 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 4 generations to K021049 (2002). 5 ancestors in all. 18 later devices descend from it, 3 citing it directly. 2 of the 24 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 deviceK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012
- Descendant · cites it directly · 10 of its ownK122234 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 7 of its ownK170752 OEC EliteOec Medical Systems, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 6 of its ownK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 5 of its ownK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK131423 G-Arm Multiscan SystemBeijing East Whale Imaging Technology Co., Ltd. · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · cites it directly10descendants
- K170752OEC EliteOec Medical Systems, Inc. · 2017 · 2 generations on7descendants
- K171565OEC EliteGe Oec Medical Systems, Inc. · 2017 · 3 generations on6descendants
- K172550OEC EliteGe Oec Medical Systems, Inc. · 2017 · 4 generations on5descendants
- K131423G-Arm Multiscan SystemBeijing East Whale Imaging Technology Co., Ltd. · 2013 · cites it directly5descendants
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) | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | — |
| +1 | K122234 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 6 |
| +2 | K170752 | OEC Elite | Oec Medical Systems, Inc. | 2017 | 4 |
| +3 | K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| +4 | K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| +1 | K131423 | G-Arm Multiscan System | Beijing East Whale Imaging Technology Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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…Classification Names: 21 CFR 892.1650 Image-intensified fluoroscopic x-ray system Product Code: 900X0 and 90JAA Predicate Device(s): K082781I OECO 9900 Elite Device Description: The OEC® 9900 Elite is a system used to assist trained… | 2009 |
What descends from it? (18)
See all 183 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-2342-2025 | 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-0705-2025 | 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-2277-2023 | 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-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 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-1060-2017 | 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-0975-2017 | 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. |
The 5 latest of 7 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 10 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K122234 (Ge Healthcare Surgery GE Oec Medical Systems, Inc., 2012) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K082781.
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. 2012, this device’s year, is highlighted.
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 OEC® 9900 Elite is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120613 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120613: Oec 9900 Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120613
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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