# K041932: Oec Olympus Fluoroscopic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems, Inc.
- Decided: Aug 18, 2004 after 30 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021049 (2002). 2 ancestors in all.
40 later devices descend from it; 3 cite it directly.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021049: Oec 9800 Plus Digital Mobile Imaging System, Ge Oec Medical Systems (2002) Summary page 1.
- K024012: Oec 9800 E/CV+ Digital Mobile Imaging System, Ge Oec Medical Systems (2003) Summary page 1.

## Most influential descendants
- 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
- K111551: Oec (R) 9800, Oec (R) 9800 Plus (2011), 12 descendants of its own
- K122234: Oec 9900 Elite (2012), 10 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.
- 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-1706-2008: Use of existing four-pedal footswitch on a different machine may cause various operational errors.
- Nov 19, 2007 · Class II · Z-2025-2012: 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-0676-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Mar 1, 2007 · Not classified · Z-0679-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.
- Mar 1, 2007 · Not classified · Z-0683-2007: During routine service, primary and/or secondary collimators may not have been properly reinstalled.

## Indications for use
The OEC Olympus Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.

Source page: https://510kreport.com/device/K041932
Methodology: https://510kreport.com/methodology