510(k) · Cleared
Recalled · Class I · 2016Oec Fluorotrak 9800 Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Oec Medical Systems · OWB Interventional Fluoroscopic X-Ray System
Cleared on Sep 17, 2002 as substantially equivalent to K974355 (Ge Dec Medical Systems, 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 4 generations to 1994. 5 of the 11 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 18 times, including a Class I recall.
- Decided
- Sep 17, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 18 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911783 (1994). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly. 5 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 3 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 2 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 1 generation backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- This deviceK022069 Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002
- Descendant · cites it directly · 1 of its ownK041931 Oec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −3 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −2 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −1 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| 0 (this device) | K022069 | Oec Fluorotrak 9800 Plus | Ge Oec Medical Systems | 2002 | — |
| +1 | K041931 | Oec Olympus Mobile Fluoroscopy System with Integrated Navigation | Ge Oec Medical Systems, Inc. | 2004 | 5 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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.
5 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 |
|---|---|---|---|
| * | K974355 | Interventional Mobile Digital Imaging System (Herein Called Imdis)Summary page 1…pic Imaging System with Interactive Image Guided Surgical System The OEC FluoroTrak 9800 Plus is substantially equivalent to the OEC 9800 Mobile Digital Imaging System (K974355) marketed by GE OEC Medical Systems, Inc. and the InstaTrak 3000 System with FluoroTrak Module (K994270) marketed by Visualizatio… | 1998 |
| * | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000Summary page 1…ntially equivalent to the OEC 9800 Mobile Digital Imaging System (K974355) marketed by GE OEC Medical Systems, Inc. and the InstaTrak 3000 System with FluoroTrak Module (K994270) marketed by Visualization Technology, Inc. Page 1-SUM 510(k) Summary OEC FluoroTrak 9800 Plus Indications for… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041931 | Oec Olympus Mobile Fluoroscopy System with Integrated Navigation | 2004 | 1 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2016 | Class II | Z-2629-2016 | Software design (manufacturing process) | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. |
| Oct 3, 2014 | Class II | Z-0195-2015 | Component design/selection | GE Healthcare initiated a field correction because prior revision of components were potentially installed on certain OEC 9800, FlexiView 8800, OEC MiniView 6800 and OEC UroView 2800 systems. |
| 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. |
| Nov 6, 2009 | Class II | Z-2240-2012 | Device Design | GE OEC is recalling certain 9800 Image Intensified Flouroscopic x-ray systems due to customer complaint analysis showing that a replacement Hitachi 160 GB Hard Drive, when installed on certain models is susceptible of causing… |
| 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-1705-2008 | Device Design | Use of existing four-pedal footswitch on a different machine may cause various operational errors. |
| Feb 22, 2008 | Class I | Z-2038-2012 | Software 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. The vertical lift column power supply in the mainframe C-arm of the device is… |
| Nov 19, 2007 | Class II | Z-2026-2012 | 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-0681-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0680-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0677-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Mar 1, 2007 | Not classified | Z-0682-2007 | Other | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Feb 9, 2007 | Not classified | Z-0557-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0556-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0558-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 9, 2007 | Not classified | Z-0559-2007 | Other | During routine service, a cover may have been installed without the required proper lead shielding. |
| Feb 6, 2006 | Not classified | Z-0709-06 | Other | Small retaining pin may detach and fall into the surgical field during stereotactic surgery. |
| Dec 13, 2004 | Not classified | Z-0692-5 | Other | Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised. |
The 5 latest of 18 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.
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 7 of the 8 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K041931 (Ge Oec Medical Systems, Inc., 2004) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K974355.
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 FluoroTrak 9800 Plus Mobile Imaging System provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The Fluorotrak 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 benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.
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/K022069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022069: Oec Fluorotrak 9800 Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022069
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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