# K052341: Ajex 9015/135H Portable X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Jpi America, Inc.
- Decided: Oct 7, 2005 after 42 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. The FDA summary names its predicate without a number.
- (no number) PXP 15/20/40 Portable X-ray units: named in the summary without a submission number

## Indications for use
The AJEX 9015/135H Portable X-rays are intended for use in general radiographic medical applications, by qualified/trained doctors or technicians on both adult and pediatric patients for taking diagnostic radiographic exposures of body parts. -The AIEX 9015H is used by foot and hand care clinics and portable orthopedic needs by sports medicine groups at sports arenas for general radiographic exposures. -The AJEX 135H is used in general radiographic mobile applications with stand, by qualified/trained doctors, technicians or nurses, for on -site and off-site patients that arc not mobile.

Source page: https://510kreport.com/device/K052341
Methodology: https://510kreport.com/methodology