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 5, 2021 as substantially equivalent to K192819 (Ge Oec Medical Systems, Inc., 2019) after a 112-day review. Its family tree reaches back 10 generations to 2002. 2 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Mar 5, 2021
- Review
- 112 days
- Class
- Class II
- Product code
- OXO
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 10 generations to K021049 (2002). 11 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 6 generations between
- 3 generations backK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK192819 OEC EliteGe Oec Medical Systems, Inc. · 2019 · Recalled
- This deviceK203346 OEC 3DGe Oec Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK233669 OEC 3DGe Oec Medical Systems, Inc. · 2024 · Recalled
Show all 10 generations
- Root · 10 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 9 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 8 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 7 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 6 generations backK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 5 generations backK122234 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 4 generations backK170752 OEC EliteOec Medical Systems, Inc. · 2017 · Recalled
- 3 generations backK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK192819 OEC EliteGe Oec Medical Systems, Inc. · 2019 · Recalled
- This deviceK203346 OEC 3DGe Oec Medical Systems, Inc. · 2021
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K233669OEC 3DGe Oec Medical Systems, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −9 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −8 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −7 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −6 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| −5 | K122234 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 6 |
| −4 | K170752 | OEC Elite | Oec Medical Systems, Inc. | 2017 | 4 |
| −3 | K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| −2 | K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| −1 | K192819 | OEC Elite | Ge Oec Medical Systems, Inc. | 2019 | 4 |
| 0 (this device) | K203346 | OEC 3D | Ge Oec Medical Systems, Inc. | 2021 | — |
| +1 | K233669 | OEC 3D | Ge Oec Medical Systems, Inc. | 2024 | 2 |
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 |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K192819 | OEC EliteSummary page 4…Salt Lake City, Utah 84116 Predicate Device: Device Name: OEC Elite 510(k) number: K192819 Manufacturer: GE OEC Medical Systems, Inc Regulation Name: Image-intensified Fluor… | 2019 |
| † | K181550 | Cios Spin | 2018 |
| † | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233669 | OEC 3D | 2024 | 0 |
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. |
| Jun 10, 2021 | Class II | Z-2160-2021 | Under Investigation by firm | There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. |
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 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 9 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 11 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K233669 (Ge Oec Medical Systems, Inc., 2024) has gone furthest, with 0 descendants of its own.
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. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203346 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203346: 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/K203346
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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