# K150725: Visaris Avanse

- Pathway: 510(k) (Traditional)
- Applicant: Visaris D.O.O. Belgrade
- Decided: Jun 8, 2015 after 80 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: 7 generations back to K896095 (1990). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091364: Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4, Oehm Und Rehbein GmbH (2009) Summary page 4.

## Most influential descendants
- K161937: CuattroDR (2016), 0 descendants of its own

## Indications for use
The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.

Source page: https://510kreport.com/device/K150725
Methodology: https://510kreport.com/methodology