510(k) · Cleared
Recalled · Class II · 2016Uroview 2800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Dec Medical Systems · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 21, 1999 as substantially equivalent to K940295 (Ge Dec Medical Systems, 1994) and 2 other predicates after a 50-day review. Its family tree reaches back 1 generation to 1990. It has been recalled 13 times.
- Decided
- Dec 21, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 13
- Predicates
- 3
Its longest line of descent runs back 1 generation to K904145 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904145 Hydra Vision Urological X-Ray SystemMallinckrodt Group, Inc. · 1990
- This deviceK993687 Uroview 2800Ge Dec Medical Systems · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904145 | Hydra Vision Urological X-Ray System | Mallinckrodt Group, Inc. | 1990 | — |
| 0 (this device) | K993687 | Uroview 2800 | Ge Dec Medical Systems | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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.
Planning a device in OWB? 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? (3)
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 |
|---|---|---|---|
| * | K940295 | Uroview Model 2600Summary page 1…ging System Urology Table Substantial Equivalence: The UroView 2800 is substantially equivalent to the following devices that are currently marketed: e OEC UroView 2600 (K940295) e Liebel-Flarsheim Hydradjust IV (K943581) o Liebel-Flarsheim HydraVision (K904145) Device Description: General Description… | 1994 |
| * | K943581 | Hydradjust IV Urological TableSummary page 1…lence: The UroView 2800 is substantially equivalent to the following devices that are currently marketed: e OEC UroView 2600 (K940295) e Liebel-Flarsheim Hydradjust IV (K943581) o Liebel-Flarsheim HydraVision (K904145) Device Description: General Description The UroView 2800 is a fluoroscopic x-ray sys… | 1995 |
| * | K904145 | Hydra Vision Urological X-Ray SystemSummary page 1…equivalent to the following devices that are currently marketed: e OEC UroView 2600 (K940295) e Liebel-Flarsheim Hydradjust IV (K943581) o Liebel-Flarsheim HydraVision (K904145) Device Description: General Description The UroView 2800 is a fluoroscopic x-ray system including a tilting patient-support t… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 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. |
| Jul 22, 2016 | Class II | Z-2628-2016 | 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-0192-2015 | 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. |
| Aug 29, 2008 | Not classified | Z-1730-2009 | Release of Material/Component prior to receiving test results | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in… |
| Aug 15, 2008 | Not classified | Z-1706-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1708-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1707-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Aug 15, 2008 | Not classified | Z-1709-2009 | Packaging process control | GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have seals that could be compromised during the shelf life of the products. This issue could result in the… |
| Jun 12, 2007 | Not classified | Z-0852-2007 | Other | X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma. |
| Mar 27, 2007 | Class II | Z-2127-2012 | 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. GE OEC had discovered an issue with the hard disk drives that were installed on… |
| Jan 15, 2007 | Not classified | Z-0514-2007 | Other | Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall. |
| Jan 15, 2007 | Not classified | Z-0515-2007 | Other | Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. . |
| Nov 20, 2006 | Class II | Z-1865-2012 | Software design | Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K940295.
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 UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications include but are not limited to urologic and endoscopic procedures. The system may be used for other imaging applications at the physician’s 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/K993687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993687: Uroview 2800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993687
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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