# K140041: Zen-7000,System,Fluroscopic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Nov 28, 2014 after 324 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K021049 (2002). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103425: Zen-7000, Fluoroscopic X-Ray System, Genoray America, Inc. (2011) Summary page 4.
- K082781: Oec 9900 Elite, Ge Healthcare Surgery (2009) Summary page 4.

## Most influential descendants
- K172180: OSCAR 15 (2018), 1 descendant of its own
- K230787: Oscar 15 & Oscar 15i (2023), 0 descendants of its own

## Indications for use
ZEN-7000 is a 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, vascular, cardiac, 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/K140041
Methodology: https://510kreport.com/methodology