# K993687: Uroview 2800

- Pathway: 510(k) (Abbreviated)
- Applicant: Ge Dec Medical Systems
- Decided: Dec 21, 1999 after 50 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904145 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940295: Uroview Model 2600, Ge Dec Medical Systems (1994) Summary page 1.
- K943581: Hydradjust IV Urological Table, Mallinckrodt Group, Inc. (1995) Summary page 1.
- K904145: Hydra Vision Urological X-Ray System, Mallinckrodt Group, Inc. (1990) Summary page 1.

## Recalls of this device
- Jul 22, 2016 · Class II · Z-2629-2016: 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: 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: 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: 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
- Aug 15, 2008 · Not classified · Z-1706-2009: 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 product
- Aug 15, 2008 · Not classified · Z-1708-2009: 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 product
- Aug 15, 2008 · Not classified · Z-1707-2009: 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 product
- Aug 15, 2008 · Not classified · Z-1709-2009: 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 product
- Jun 12, 2007 · Not classified · Z-0852-2007: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- Mar 27, 2007 · Class II · Z-2127-2012: 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 h
- Jan 15, 2007 · Not classified · Z-0514-2007: 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: 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
- Nov 20, 2006 · Class II · Z-1865-2012: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K993687
Methodology: https://510kreport.com/methodology