# K171565: OEC Elite

- Pathway: 510(k) (Traditional)
- Applicant: Ge Oec Medical Systems, Inc.
- Decided: Aug 10, 2017 after 72 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K021049 (2002). 8 ancestors in all.
6 later devices descend from it; 1 cites it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170752: OEC Elite, Oec Medical Systems, Inc. (2017) Summary page 5.

## Most influential descendants
- K172550: OEC Elite (2017), 5 descendants of its own
- K192819: OEC Elite (2019), 2 descendants of its own
- K203346: OEC 3D (2021), 1 descendant of its own
- K200218: Digiscan FDX (2020), 1 descendant of its own
- K253296: Digital C-ARM with 3D (2026), 0 descendants of its own

## Recalls of this device
- Mar 21, 2025 · Class II · Z-1819-2025: OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
- Nov 21, 2024 · Class II · Z-0704-2025: 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-2278-2023: 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 
- Jun 10, 2021 · Class II · Z-2161-2021: There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.

## Indications for use
The OEC Elite mobile fluoroscopy system is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.

Source page: https://510kreport.com/device/K171565
Methodology: https://510kreport.com/methodology