# K182134: ARiX RAD Radiographic System

- Pathway: 510(k) (Traditional)
- Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Decided: Nov 26, 2018 after 112 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981556 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090279: Sedecal, Millennium Plus, Sedecal., Sa. (2009) Summary page 4.

## Most influential descendants
- K193637: MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System (2020), 0 descendants of its own

## Indications for use
The ARiX RAD system is a radiographic system used for producing X-ray images of the human body, including all anatomical regions such as the head, thorax, column, abdomen, extremities and internal organs. The system is design to be used with conventional film or CR systems and can be interfaced with a digital detector, but neither the X-Ray detector nor the image acquisition system are part of the ARiX RAD radiographic system. The acquisition system comes as a separate system. The ARiX RAD system is not intended for use in mammography, fluoroscopy or angiography. The ARiX RAD system is intended for adults and pediatric patients. The pediatric population is as follows: • Child (3–12 yrs.), approximately 12 kg (26 lb.) to 51 kg (114 lb.) • Adolescent (12–21 yrs.), approximately 51 kg (114 lb.) to 80 kg (176 lb.)

Source page: https://510kreport.com/device/K182134
Methodology: https://510kreport.com/methodology