# K061953: 9900 Plus Mobile Fluoroscopy System with 3D and Navigation Options

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems
- Decided: Aug 15, 2006 after 36 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911783 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
7 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041932: Oec Olympus Fluoroscopic Imaging System, Ge Oec Medical Systems, Inc. (2004) Summary page 1.
- K041931: Oec Olympus Mobile Fluoroscopy System with Integrated Navigation, Ge Oec Medical Systems, Inc. (2004) Summary page 1.

## Recalls of this device
- Mar 31, 2014 · Class II · Z-1462-2014: GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and 

## Indications for use
The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urolagic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology. The 93900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Plus 3D is intended for imaging bone and soft tissues as well as other interal body structures. 9900 Plus 3D is not intended for mammography applications. The surgical Navigation feature is intended as an aid to the surgeon for locating analomical structures anywhere on the human body during either open or percutaneous procedures. Itis 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. The system may be used for other imaging applications at the physicians discretion.

Source page: https://510kreport.com/device/K061953
Methodology: https://510kreport.com/methodology