# K041931: Oec Olympus Mobile Fluoroscopy System with Integrated Navigation

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems, Inc.
- Decided: Aug 26, 2004 after 38 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K911783 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022069: Oec Fluorotrak 9800 Plus, 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
- K061953: 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options (2006), 0 descendants of its own

## Recalls of this device
- Jul 6, 2007 · Not classified · Z-0989-2007: 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-0848-2007: X-ray systems were not configured to display Air Kerma Rate and Cumulative Air Kerma.
- Sep 30, 2006 · Not classified · Z-0042-2007: X-ray system may lose or mix images and/or lose patient data.
- Sep 13, 2006 · Not classified · Z-0041-2007: Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
- Aug 16, 2006 · Not classified · Z-1301-06: X-ray systems could provide output which exceeds the 20 R/minute limit.

## Indications for use
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images during diagnostic, surgical and interventional procedures. The 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 be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.

Source page: https://510kreport.com/device/K041931
Methodology: https://510kreport.com/methodology