# K160579: Xmaru View V1 and Xmaru PACS, Medical Image Processing Software

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Apr 8, 2016 after 38 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.
5 later devices descend from it; 3 cite 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)
- K102078: Radiological Image Processing System, VATECH Co., Ltd. (2011) Summary page 7.

## Most influential descendants
- 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
- K183478: ClearON Mobile (2019), 0 descendants of its own

## Indications for use
XmaruView V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. XmaruView V1(Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems. Xmaru PACS receives, stores, searches and views the diagnostic image data from imaging modalities in DICOM compliant. Xmaru PACS is capable of communicating with electronic medical records systems, hospital information systems, and radiology information system via DICOM standard. XmaruView V1(Xmaru Chiroview or Xmaru Podview) and Xmaru PACS can be packaged together or offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals.

Source page: https://510kreport.com/device/K160579
Methodology: https://510kreport.com/methodology