510(k) · Cleared
Recalled · 2007Oec Olympus Mobile Fluoroscopy System with Integrated Navigation
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 26, 2004 as substantially equivalent to K022069 (Ge Oec Medical Systems, 2002) and 1 other predicate after a 38-day review. Its family tree reaches back 5 generations to 1994. 6 of the 12 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Aug 26, 2004
- Review
- 38 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 5 generations to K911783 (1994). 10 ancestors in all. 1 later device descends from it, 1 citing it directly. 6 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 4 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 3 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 2 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 1 generation backK022069 Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · Recalled (Class I)
- This deviceK041931 Oec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK061953 9900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsGe Oec Medical Systems · 2006 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K0619539900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsGe Oec Medical Systems · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −4 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −3 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −2 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −1 | K022069 | Oec Fluorotrak 9800 Plus | Ge Oec Medical Systems | 2002 | Class I |
| 0 (this device) | K041931 | Oec Olympus Mobile Fluoroscopy System with Integrated Navigation | Ge Oec Medical Systems, Inc. | 2004 | — |
| +1 | K061953 | 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options | Ge Oec Medical Systems | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 1 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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.
6 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 |
|---|---|---|---|
| * | K022069 | Oec Fluorotrak 9800 PlusSummary page 1…uoroscopy System with Integrated Navigation is substantially equivalent to the: * OEC FluoroTrak 9800 Plus (K022069) marketed by GE OEC Medical Systems, Inc. * OEC 9800 E/CV+ Digi… | 2002 |
| * | K024012 | Oec 9800 E/CV+ Digital Mobile Imaging SystemSummary page 1…ak 9800 Plus (K022069) marketed by GE OEC Medical Systems, Inc. * OEC 9800 E/CV+ Digital Mobile System (K024012) marketed by GE OEC Medical Systems, Inc. Page 1-SUM… | 2003 |
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 |
|---|---|---|---|
| K061953 | 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options | 2006 | 0 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2007 | Not classified | Z-0989-2007 | Other | The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions. |
| Jun 12, 2007 | Not classified | Z-0848-2007 | Other | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| Sep 30, 2006 | Not classified | Z-0042-2007 | Other | X-ray system may lose or mix images and/or lose patient data. |
| Sep 13, 2006 | Not classified | Z-0041-2007 | Other | Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy. |
| Aug 16, 2006 | Not classified | Z-1301-06 | Other | X-ray systems could provide output which exceeds the 20 R/minute limit. |
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
- K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 10 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K061953 (Ge Oec Medical Systems, 2006) has gone furthest, with 0 descendants of its own.
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 with Integrated Navigation provides the physician with fluoroscopic images during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041931: Oec Olympus Mobile Fluoroscopy System with Integrated Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041931
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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