# K073543: Oec 9900 Elite

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems
- Decided: May 2, 2008 after 137 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: 2 generations back to K021049 (2002). 3 ancestors in all.
38 later devices descend from it; 3 cite it directly.
2 of 42 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.

## Most influential descendants
- 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
- K170752: OEC Elite (2017), 7 descendants of its own

## Recalls of this device
- Jul 2, 2025 · Class II · Z-2342-2025: GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape i
- Nov 21, 2024 · Class II · Z-0705-2025: Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
- May 15, 2023 · Class II · Z-2277-2023: 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-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 
- 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 OEC® 9900 Elite 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, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.

Source page: https://510kreport.com/device/K073543
Methodology: https://510kreport.com/methodology