# K021049: Oec 9800 Plus Digital Mobile Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems
- Decided: Apr 17, 2002 after 16 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 26 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
76 later devices descend from it; 6 cite it directly.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) OEC 9800 Digital Mobile Imaging System: named in the summary without a submission number

## Most influential descendants
- K041932: Oec Olympus Fluoroscopic Imaging System (2004), 40 descendants of its own
- K073543: Oec 9900 Elite (2008), 38 descendants of its own
- K082781: Oec 9900 Elite (2009), 35 descendants of its own
- K120613: Oec 9900 Elite (2012), 18 descendants of its own
- K061203: Ziehm Vision R Digital Mobile Imaging System (2006), 18 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 
- 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.
- Apr 26, 2010 · Class II · Z-2241-2012: 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: 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 
- Oct 10, 2008 · Class II · Z-2262-2012: GE initiated a correction to the instructions/use due to the potential for erroneous auto injection of contrast dye.
- 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
- Apr 15, 2008 · Not classified · Z-1705-2008: Use of existing four-pedal footswitch on a different machine may cause various operational errors.
- Feb 22, 2008 · Class I · Z-2038-2012: 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. The vertical lift column power supply in 
- Nov 19, 2007 · Class II · Z-2026-2012: 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 recalled imaging devices OEC 9900,
- Mar 27, 2007 · Class II · Z-2125-2012: 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
- Mar 1, 2007 · Not classified · Z-0681-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Mar 1, 2007 · Not classified · Z-0680-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Mar 1, 2007 · Not classified · Z-0677-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Mar 1, 2007 · Not classified · Z-0682-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Feb 9, 2007 · Not classified · Z-0557-2007: During routine service, a cover may have been installed without the required proper lead shielding.
- Feb 9, 2007 · Not classified · Z-0556-2007: During routine service, a cover may have been installed without the required proper lead shielding.
- Feb 9, 2007 · Not classified · Z-0558-2007: During routine service, a cover may have been installed without the required proper lead shielding.
- Feb 9, 2007 · Not classified · Z-0559-2007: During routine service, a cover may have been installed without the required proper lead shielding.

## Indications for use
The OEC 9800 Plus Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Examples of clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician’s discretion.

Source page: https://510kreport.com/device/K021049
Methodology: https://510kreport.com/methodology