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 · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 1, 2009 as substantially equivalent to K041932 (Ge Oec Medical Systems, Inc., 2004) and 1 other predicate after a 221-day review. Its family tree reaches back 3 generations to 2002. 2 of the 40 devices in its family, counting itself, have a Class I recall. 35 later devices descend from it. It has been recalled 4 times.
- Decided
- May 1, 2009
- Review
- 221 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 3 generations to K021049 (2002). 4 ancestors in all. 35 later devices descend from it, 3 citing it directly. 2 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 2 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 1 generation backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- This deviceK082781 Oec 9900 EliteGe Healthcare Surgery · 2009
- Descendant · cites it directly · 18 of its ownK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- Descendant · cites it directly · 12 of its ownK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 10 of its ownK122234 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 7 of its ownK170752 OEC EliteOec Medical Systems, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 6 of its ownK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 35 · See all- K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · cites it directly18descendants
- K111551Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · cites it directly12descendants
- K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · 2 generations on10descendants
- K170752OEC EliteOec Medical Systems, Inc. · 2017 · 3 generations on7descendants
- K171565OEC EliteGe Oec Medical Systems, Inc. · 2017 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −2 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −1 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| 0 (this device) | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | — |
| +1 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| +1 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| +2 | K122234 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 6 |
| +3 | K170752 | OEC Elite | Oec Medical Systems, Inc. | 2017 | 4 |
| +4 | K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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 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? (2)
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 |
|---|---|---|---|
| * | K041932 | Oec Olympus Fluoroscopic Imaging SystemSummary page 1…2.1720 (either) Image-intensified fluoroscopic x-ray system and Mobile x-ray system. Product Code: 90JAA and 901ZL. Predicate Device: K041932 GEC Olympus Fluoroscopic Imaging System, K073543 OEC 9900 Elite Device Description: The DEC® 99… | 2004 |
| * | K073543 | Oec 9900 EliteSummary page 1…Mobile x-ray system. Product Code: 90JAA and 901ZL. Predicate Device: K041932 GEC Olympus Fluoroscopic Imaging System, K073543 OEC 9900 Elite Device Description: The DEC® 9900 Elite mobile fluoroscopy system is an image intensified fluoroscopic… | 2008 |
What descends from it? (35)
See all 353 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… |
| Mar 31, 2014 | Class II | Z-1462-2014 | Device Design | GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward. |
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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 4 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K120613 (Ge Healthcare Surgery GE Oec Medical Systems, Inc., 2012) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K041932.
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. 2009, 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® 9900 Elite mobile fluoroscopy system 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. The system may be used for other imaging applications at the physician's discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082781: Oec 9900 Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082781
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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