510(k) · Cleared
Recalled · Class II · 2025OEC 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems, Inc. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Mar 28, 2024 as substantially equivalent to K203346 (Ge Oec Medical Systems, Inc., 2021) after a 134-day review. Its family tree reaches back 11 generations to 2002. 2 of the 13 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.
- Decided
- Mar 28, 2024
- Review
- 134 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 11 generations to K021049 (2002). 12 ancestors in all. No later device cites it as a predicate yet. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 7 generations between
- 3 generations backK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK192819 OEC EliteGe Oec Medical Systems, Inc. · 2019 · Recalled
- 1 generation backK203346 OEC 3DGe Oec Medical Systems, Inc. · 2021 · Recalled
- This deviceK233669 OEC 3DGe Oec Medical Systems, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 10 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 9 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 8 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 7 generations backK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 6 generations backK122234 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 5 generations backK170752 OEC EliteOec Medical Systems, Inc. · 2017 · Recalled
- 4 generations backK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 3 generations backK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK192819 OEC EliteGe Oec Medical Systems, Inc. · 2019 · Recalled
- 1 generation backK203346 OEC 3DGe Oec Medical Systems, Inc. · 2021 · Recalled
- This deviceK233669 OEC 3DGe Oec Medical Systems, Inc. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −10 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −9 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −8 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −7 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| −6 | K122234 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 6 |
| −5 | K170752 | OEC Elite | Oec Medical Systems, Inc. | 2017 | 4 |
| −4 | K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| −3 | K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| −2 | K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019 | 4 |
| −1 | K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021 | 3 |
| 0 (this device) | K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
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 |
|---|---|---|---|
| * | K203346 | OEC 3DSummary page 4…Salt Lake City, Utah 84116 Predicate Device: Device Name: OEC 3D 510(k) number: K203346 Manufacturer: GE OEC Medical Systems, Inc Page 1 of… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2025 | Class II | Z-1820-2025 | Process control | OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field. |
| Nov 21, 2024 | Class II | Z-0703-2025 | 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. |
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 · 10 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 10 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
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. 2024, 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 3D mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, cardiac, critical care, and emergency procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233669: OEC 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233669
Report an extraction error
Are you the manufacturer?
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