# K024012: Oec 9800 E/CV+ Digital Mobile Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems
- Decided: Mar 20, 2003 after 106 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 20 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
59 later devices descend from it; 4 cite it directly.
1 of 60 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) GE OEC Medical Systems - OEC 9800 Plus Mobile Digital Imaging System: named in the summary without a submission number
- (no number) Siemens Medical Solutions - Powermobil: 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
- 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 12, 2008 · Not classified · Z-1885-2008: Beam limitation may be non-compliant on some X-ray units.
- Aug 12, 2008 · Not classified · Z-1884-2008: Beam limitation may be non-compliant on some X-ray units.
- 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,
- Jul 6, 2007 · Not classified · Z-0990-2007: The Air Kerma Rate displayed value and cumulative air kerma displayed value could exceed the allowable error under certain imaging conditions.
- Jun 12, 2007 · Not classified · Z-0849-2007: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- 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.
- Aug 16, 2006 · Not classified · Z-1302-06: X-ray systems could provide output which exceeds the 20 R/minute limit.
- May 31, 2006 · Not classified · Z-0001-2007: Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.

## Indications for use
The OEC 9800 E/CV+ Digital Mobile Imaging System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. It includes features designed specifically for diagnostic and interventional cardiac imaging procedures, and is also intended for use in cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may also be used for other imaging applications at the physician’s discretion.

Source page: https://510kreport.com/device/K024012
Methodology: https://510kreport.com/methodology