510(k) · Cleared
Recalled · Class II · 2010Oec Olympus Fluoroscopic Imaging System
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 Aug 18, 2004 as substantially equivalent to K021049 (Ge Oec Medical Systems, 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 2002. 2 of the 43 devices in its family, counting itself, have a Class I recall. 40 later devices descend from it. It has been recalled 7 times.
- Decided
- Aug 18, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K021049 (2002). 2 ancestors in all. 40 later devices descend from it, 3 citing it directly. 2 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- This deviceK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004
- Descendant · cites it directly · 38 of its ownK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- Descendant · cites it directly · 35 of its ownK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- Descendant · 2 generations on · 18 of its ownK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 12 of its ownK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 10 of its ownK122234 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 40 · See all- K073543Oec 9900 EliteGe Oec Medical Systems · 2008 · cites it directly38descendants
- K082781Oec 9900 EliteGe Healthcare Surgery · 2009 · cites it directly35descendants
- K120613Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · 2 generations on18descendants
- K111551Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · 2 generations on12descendants
- K122234Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| 0 (this device) | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | — |
| +1 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| +1 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| +2 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| +2 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| +3 | K122234 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 6 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K021049 | Oec 9800 Plus Digital Mobile Imaging SystemSummary page 1…luoroscopy System is substantially equivalent to the: * OEC 9800 Plus Digital Mobile Imaging System (K021049) marketed by GE OEC Medical Systems, Inc. * OEC 9800 E/… | 2002 |
| * | K024012 | Oec 9800 E/CV+ Digital Mobile Imaging SystemSummary page 1…tem (K021049) marketed by GE OEC Medical Systems, Inc. * OEC 9800 E/CV+ Digital Mobile Systems (K024012) marketed by GE OEC Medical Systems, Inc. Pa… | 2003 |
What descends from it? (40)
See all 403 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 |
|---|---|---|---|---|
| Apr 26, 2010 | Class II | Z-2241-2012 | Component change control | GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not conform to the IEC 60601-1 standard for clearance and creepage of voltage isolation. |
| Oct 10, 2008 | Class II | Z-2262-2012 | Device Design | GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye. |
| Apr 15, 2008 | Not classified | Z-1706-2008 | Device Design | Use of existing four-pedal footswitch on a different machine may cause various operational errors. |
| Nov 19, 2007 | Class II | Z-2025-2012 | Device Design | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of… |
| Mar 1, 2007 | Not classified | Z-0676-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0679-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0683-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
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 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
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.
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 Olympus 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 physicians discretion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041932: Oec Olympus Fluoroscopic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041932
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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