# K111551: Oec (R) 9800, Oec (R) 9800 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems, Inc.
- Decided: Oct 4, 2011 after 123 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021049 (2002). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
2 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082781: Oec 9900 Elite, Ge Healthcare Surgery (2009) Summary page 1.

## Most influential descendants
- K132027: Oec 9800 Plus (2014), 6 descendants of its own
- K183109: ControlRad Trace Model 8 (2019), 4 descendants of its own
- K123603: Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime (2013), 4 descendants of its own
- K200663: ControlRad Trace Model 9 (2020), 3 descendants of its own
- K172700: OEC One (2017), 3 descendants of its own

## Recalls of this device
- Jul 2, 2025 · Class II · Z-2341-2025: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape i
- Nov 21, 2024 · Class II · Z-0706-2025: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
- May 15, 2023 · Class II · Z-2279-2023: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier 
- May 15, 2023 · Class II · Z-2276-2023: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier 
- May 8, 2020 · Class II · Z-2872-2020: GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE)
- Dec 27, 2016 · Class II · Z-1059-2017: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenan
- Dec 19, 2016 · Class II · Z-0973-2017: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord fail
- 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.
- Oct 3, 2014 · Class II · Z-0195-2015: 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.

## Indications for use
The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Source page: https://510kreport.com/device/K111551
Methodology: https://510kreport.com/methodology