# K122234: Oec 9900 Elite

- Pathway: 510(k) (Special)
- Applicant: Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Decided: Aug 16, 2012 after 21 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K021049 (2002). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120613: Oec 9900 Elite, Ge Healthcare Surgery GE Oec Medical Systems, Inc. (2012) Summary page 1.

## Most influential descendants
- K170752: OEC Elite (2017), 7 descendants of its own
- K171565: OEC Elite (2017), 6 descendants of its own
- K172550: OEC Elite (2017), 5 descendants of its own
- K192819: OEC Elite (2019), 2 descendants of its own
- K250010: Extron 3; Extron 5; Extron 7 (2025), 1 descendant 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 8, 2020 · Class II · Z-2872-2020: GEHC Surgery became aware that some users of the 9800 and 9900 fluoroscopic mobile C-Arms (referred to as the system here on) within the United States had requested that a Field Service Engineer (FSE)
- Dec 27, 2016 · Class II · Z-1060-2017: GE Healthcare Surgery announces a voluntary field action for the OEC 9800 and OEC 9900 Elite due to additional supplementation to the user documentation to include areas for enhanced planned maintenan
- Dec 19, 2016 · Class II · Z-0975-2017: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord fail

## Indications for use
The OEC® 9900 Elite 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.

Source page: https://510kreport.com/device/K122234
Methodology: https://510kreport.com/methodology