# K102078: Radiological Image Processing System

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Aug 10, 2011 after 380 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: 7 generations back to K896095 (1990). 9 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 16 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 2.

## Most influential descendants
- K160579: Xmaru View V1 and Xmaru PACS, Medical Image Processing Software (2016), 5 descendants of its own
- K191188: ASHK100G (2019), 2 descendants of its own
- K212137: X-Clever (2021), 1 descendant of its own
- K233599: X-Clever (ASHK100G) (2024), 0 descendants of its own
- K190866: XmaruView V1 (Xmaru Chiroview, Xmaru Podview) (2019), 0 descendants of its own

## Indications for use
XmaruView V I software is to make the processing and administration of medical X-ray images as efficient as possible. Functions to be carried out using XmaruView VI is, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1 software can control X-ray generator acquisition settings. XmaruView VI is not approved for the acquisition of mammographic image data and it cannot be used to interpret mammographic image date either. Xmai-uView VI is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data. XmaruView VI is complying with DICOM standards to assure optimum communications between network systems.

Source page: https://510kreport.com/device/K102078
Methodology: https://510kreport.com/methodology