# K022069: Oec Fluorotrak 9800 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems
- Decided: Sep 17, 2002 after 84 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 18 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911783 (1994). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974355: Interventional Mobile Digital Imaging System (Herein Called Imdis), Ge Dec Medical Systems (1998) Summary page 1.
- K994270: Instatrak 3000 System with Fluorotrak Module, Model IT3000, Visualization Technology, Inc. (2000) Summary page 1.

## Most influential descendants
- K041931: Oec Olympus Mobile Fluoroscopy System with Integrated Navigation (2004), 1 descendant of its own
- K061953: 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options (2006), 0 descendants of its own

## 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.
- 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.
- 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 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.
- Feb 6, 2006 · Not classified · Z-0709-06: Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
- Dec 13, 2004 · Not classified · Z-0692-5: Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.

## Indications for use
The OEC FluoroTrak 9800 Plus Mobile Imaging System provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The Fluorotrak surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is 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.

Source page: https://510kreport.com/device/K022069
Methodology: https://510kreport.com/methodology