# K200022: FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Livermoretech, Inc.
- Decided: Apr 3, 2020 after 88 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: 3 generations back to K973598 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032761: KMC-950 C-Arm Mobile System, United Radiology Systems, Inc. (2004) Summary page 4.

## Indications for use
The FLUSION-9001 fluoroscopic C-arm Mobile X-ray System is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.

Source page: https://510kreport.com/device/K200022
Methodology: https://510kreport.com/methodology