# K043379: Shimadzu Surgical Mobile C-Arm Imaging X-Ray System, Model Wha-200

- Pathway: 510(k) (Abbreviated)
- Applicant: Shimadzu Corp.
- Decided: Feb 17, 2005 after 71 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is a Surgical Mobile C-arm Imaging X-ray System and allows a technician to examine a patient by fluoroscopy or radiography. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient populations.

Source page: https://510kreport.com/device/K043379
Methodology: https://510kreport.com/methodology