510(k) · Cleared
Recalled · Class II · 20149900 Plus Mobile Fluoroscopy System with 3D and Navigation Options
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 Aug 15, 2006 as substantially equivalent to K041932 (Ge Oec Medical Systems, Inc., 2004) and 1 other predicate after a 36-day review. Its family tree reaches back 6 generations to 1994. 7 of the 14 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Aug 15, 2006
- Review
- 36 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K911783 (1994). 13 ancestors in all. No later device cites it as a predicate yet. 7 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 4 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 3 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 2 generations backK022069 Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · Recalled (Class I)
- 1 generation backK041931 Oec Olympus Mobile Fluoroscopy System with Integrated NavigationGe Oec Medical Systems, Inc. · 2004 · Recalled
- This deviceK061953 9900 Plus Mobile Fluoroscopy System with 3D and Navigation OptionsGe Oec Medical Systems · 2006
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −5 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −4 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −3 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −2 | K022069 | Oec Fluorotrak 9800 Plus | Ge Oec Medical Systems | 2002 | Class I |
| −1 | K041931 | Oec Olympus Mobile Fluoroscopy System with Integrated Navigation | Ge Oec Medical Systems, Inc. | 2004 | 5 |
| 0 (this device) | K061953 | 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options | Ge Oec Medical Systems | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 1 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2004 | 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.
7 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 |
|---|---|---|---|
| * | K041932 | Oec Olympus Fluoroscopic Imaging SystemSummary page 1…maging System or Mobile C-arm. Substantial Equivalence: The GE OEC 9900 Plus Mobile Digital C-Arm is substantially equivalent to the: e GE OEC 9300 Elite Mobile C-Arm (K041932) marketed by GE OEC Medical Systems, Inc. e GE OEC 9900 Elite™" Mobile C-Arm (K041931) marketed by GE OEC Medical Systems, Inc.… | 2004 |
| * | K041931 | Oec Olympus Mobile Fluoroscopy System with Integrated NavigationSummary page 1…gital C-Arm is substantially equivalent to the: e GE OEC 9300 Elite Mobile C-Arm (K041932) marketed by GE OEC Medical Systems, Inc. e GE OEC 9900 Elite™" Mobile C-Arm (K041931) marketed by GE OEC Medical Systems, Inc. Summary - Page i 510(k) Notification GE Healthcare 6900 Plus Indicati… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2014 | Class II | Z-1462-2014 | Device Design | GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward. |
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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 13 ancestors have a recall of any class; 7 have a Class I recall.
- 2 other devices also cite its predicate K041932.
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 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urolagic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier…
Read the full statement (192 words)
The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urolagic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology.
The 93900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Plus 3D is intended for imaging bone and soft tissues as well as other interal body structures. 9900 Plus 3D is not intended for mammography applications.
The surgical Navigation feature is intended as an aid to the surgeon for locating analomical structures anywhere on the human body during either open or percutaneous procedures. Itis 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. The system may be used for other imaging applications at the physicians discretion.
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/K061953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061953: 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061953
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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