# K033066: Xiscan 4000 Transportable Imaging System

- Pathway: 510(k) (Special)
- Applicant: Xitec Holdings, LLC
- Decided: Nov 12, 2003 after 44 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
Longest line of descent: 1 generation back to K003568 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003568: Xiscan 6000 Imaging System, Xitec, Inc. (2000) Summary page 1.

## Indications for use
The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

Source page: https://510kreport.com/device/K033066
Methodology: https://510kreport.com/methodology