# K233200: XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

- Pathway: 510(k) (Traditional)
- Applicant: Gemss Healthcare CO., LTD.
- Decided: Nov 16, 2023 after 49 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: 2 generations back to K010435 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091918: Zen-2090 Pro, Fluoroscopic X-Ray System, Model Zen-2090 Pro, Genoray Co., Ltd. (2009) Summary page 4.

## Indications for use
XPlus 35 Series (XPLUS 35, XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, 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/K233200
Methodology: https://510kreport.com/methodology