# K233380: TRIDENT Mobile Fluoroscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Dornier Medtech America
- Decided: Jun 26, 2024 after 268 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- 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: 5 generations back to K021049 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
2 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120613: Oec 9900 Elite, Ge Healthcare Surgery GE Oec Medical Systems, Inc. (2012) Summary page 4.

## Indications for use
The Trident 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.

Source page: https://510kreport.com/device/K233380
Methodology: https://510kreport.com/methodology