# K213520: Axir-CX

- Pathway: 510(k) (Traditional)
- Applicant: Radisen Co., Ltd.
- Decided: Aug 19, 2022 after 289 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K930527 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162868: Exam Vue PACS, Jpi Healthcare Solutions, Inc. (2017) Summary page 4.

## Indications for use
AXIR-CX is a software package used with general purpose computing hardware to receive, store, distribute and display chest X-ray images and associated data for patient diagnosis. AXIR-CX is a software application that enable the DICOM-compliant chest X-ray image [14 x 17 or 17 x 17 inch size] from DR and CR, and after image displaying the user adds the annotation regarding the diagnosis and print out the patient information or send to another PACS system. AXIR-CX is intended to be used by trained medical professionals including physicians, radiologists, and medical technicians. This device is not indicated for use in mammography.

Source page: https://510kreport.com/device/K213520
Methodology: https://510kreport.com/methodology