# K170729: Examion X-AQS

- Pathway: 510(k) (Traditional)
- Applicant: Examion GmbH
- Decided: Jul 18, 2017 after 131 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: 9 generations back to K896095 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123650: Arix Rad Acquisition Console, Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. (2013) Summary page 4.

## Indications for use
The Examion X-AQS™ 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 Examion X-AQS™ 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.x by using DICOM and network systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians. Contraindications: Examion X-AQS™ is not intended for creation of fluoroscopic/radioscopic, or angiographic images. The main functions of the Examion X-AQS™ system are: 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, ¢) 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 Examion X-AQS™, The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the Examion X-AQS™ system since the Examion X-AQS™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The Examion X-AQS™ 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 Examion X-AQS™ system does not control exposure and electrical charge and calibration X-ray. If the X-ray generator does not allow interfacing with external software the Examion X-AQS™ software cannot be interfaced with X-ray Generator.

Source page: https://510kreport.com/device/K170729
Methodology: https://510kreport.com/methodology