# K003837: Flexiview 8800 Digital Mobile Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems
- Decided: Mar 12, 2001 after 90 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 9 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
86 later devices descend from it; 3 cite it directly.
2 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032280: Siremobil Iso-C 3D (2003), 83 descendants of its own
- K050996: O-Arm Imaging System (2005), 52 descendants of its own
- K060344: O-Arm Imaging System (2006), 51 descendants of its own
- K081672: C-Insight (2008), 33 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own

## Recalls of this device
- 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-2275-2023: 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 
- Feb 21, 2017 · Class II · Z-1469-2017: OEC FlexiView 8800 workstation power cable assembly issue which can result in a loss of imaging functionality due to intermittent power cord failures.
- Oct 3, 2014 · Class II · Z-0194-2015: 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.
- Nov 19, 2007 · Class II · Z-2027-2012: 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,
- Oct 19, 2007 · Class II · Z-2221-2012: X-ray units did not meet manufacturer's specification for linearity.
- Jun 12, 2007 · Not classified · Z-0850-2007: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- Mar 1, 2007 · Not classified · Z-0678-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Nov 20, 2006 · Class I · Z-2065-2012: 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 OEC 8800 Flexview was recalled in Nov

Source page: https://510kreport.com/device/K003837
Methodology: https://510kreport.com/methodology