# K103425: Zen-7000, Fluoroscopic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Genoray America, Inc.
- Decided: Mar 29, 2011 after 127 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: 1 generation back to K021049 (2002). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021049: Oec 9800 Plus Digital Mobile Imaging System, Ge Oec Medical Systems (2002) Summary page 1.

## Most influential descendants
- K140041: Zen-7000,System,Fluroscopic X-Ray System (2014), 2 descendants of its own
- 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 Digital mobile Imaging system is designed to provide fluoroscopic and spot-film imaging 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/K103425
Methodology: https://510kreport.com/methodology