# K122298: Ajex 1200 H / Ajex 240H Mobile X-Ray Generator

- Pathway: 510(k) (Traditional)
- Applicant: Ajex Meditech., Ltd.
- Decided: Mar 28, 2014 after 605 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) MinXray HF100+: named in the summary without a submission number
- (no number) HF120/60Hz PowerPlus: named in the summary without a submission number

## Indications for use
This equipment is used for generating X-ray to get the X-ray image for the purpose of diagnosis of patient. This equipment is possible to move the place for patient because it is designed for portable type. This equipment is possible to combine with the mobile stand unit for convenience for patient positioning according to user's needs. The AJEX 1200H/ AJEX 240H Mobile X-ray Generator is designed for the following applications: - Physician with general practice - Bedside exposures in hospital ward - Surgery and Orthopedics

Source page: https://510kreport.com/device/K122298
Methodology: https://510kreport.com/methodology