# K091918: Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Oct 7, 2009 after 99 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 K010435 (2001). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043076: GE Oec Fluorostar, Ge Oec Medical Systems, Inc. (2004) Summary page 1.
- K010435: Philips BV Pulsera/Endura, Philips Medical Systems, Inc. (2001) Summary page 2.

## Most influential descendants
- K181943: OSCAR (OSCAR Prime, OSCAR Classic) (2018), 1 descendant of its own
- K252229: Belliger Ace (2026), 0 descendants of its own
- K233200: XPLUS 35 Series (XPLUS 35, XPLUS 35FD) (2023), 0 descendants of its own
- K211780: ZEN-2090 Turbo (2022), 0 descendants of its own

## Indications for use
ZEN-2090 Pro is a mobile digital C-arm designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, orthopedic, neurologic, stone localization, critical care and emergency room procedures i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.

Source page: https://510kreport.com/device/K091918
Methodology: https://510kreport.com/methodology