# K032628: Portable X-Ray Unit, Models PXP-15/20/40HF

- Pathway: 510(k) (Traditional)
- Applicant: United Radiology Systems, Inc.
- Decided: Feb 2, 2004 after 160 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- 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
PXP-HF family of portable X-Ray systems are designed for a general radiographic application in a field or medical clinics use. There are only difference in radiation output and x-ray tube between the portable X-Ray systems. PXP-20HF and PXP-40HF portables are used with mobile stand systems for Nursing home-care or Private home-care application. When the patients are sick at home, it is very expensive to bring the patients to a hospital by ambulance transportation service for X-ray examination. Therefore hospital sends this portable equipment to the patient's houses and take a X-ray picture on site. This portable and mobile systems has been used on a battle field because Of easy mobility. PXP-15HF portable X-ray systems has been used for Foot & Hand- care clinics or sport medicine group in sport complex or sport stadium for X-ray examination of athletics who are injured during a game.

Source page: https://510kreport.com/device/K032628
Methodology: https://510kreport.com/methodology