# K123650: Arix Rad Acquisition Console

- Pathway: 510(k) (Traditional)
- Applicant: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.
- Decided: Feb 20, 2013 after 85 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: 8 generations back to K896095 (1990). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110033: Feel-DRCS, Imfou Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K182537: RADMAX Digital Imaging Software (2019), 0 descendants of its own
- K170729: Examion X-AQS (2017), 0 descendants of its own

## Indications for use
The ARiX RAD Acquisition Console™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. The ARiX RAD Acquisition Console™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.0 by using DICOM and network systems. The ARiX RAD Acquisition Console™ system is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only and users must be qualified to create and diagnose radiological image data. The main functions of the ARiX RAD Acquisition Console™ system are as follows: a) Acquisition and storage of digital X-ray images from a digital X-ray Detector. b) Input Study information (patient information, exam information). c) Management of stored (archived) images. d) Image processing for enhancement of archived images. e) Review of stored images. f) Editing of images. g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) h) For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) or a need to interface with installed X-ray system, the: • Ability to configure X-ray exposure condition (kVp, mA, Sec etc) for various body parts and positions. • Communication between Generator Console and ARiX RAD Acquisition Console™ system. The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the ARiX RAD Acquisition Console™ system since the ARiX RAD Acquisition Console™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The ARiX RAD Acquisition Console™ system can only select or change values of X-ray exposure parameters (kVp, mA second or kVp; mAs) according to the defined value determined by each X-ray company. The ARiX RAD Acquisition Console™ system does not control exposure and electrical change and calibration X-ray. If the X-ray generator does not allow interfacing with external software (e.g. ARiX RAD Acquisition Console™ system), the ARiX RAD Acquisition Console™ system software cannot be interfaced with X-ray Generator.

Source page: https://510kreport.com/device/K123650
Methodology: https://510kreport.com/methodology