# K190866: XmaruView V1 (Xmaru Chiroview, Xmaru Podview)

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Apr 30, 2019 after 27 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)
- K160579: Xmaru View V1 and Xmaru PACS, Medical Image Processing Software, Rayence Co., Ltd. (2016) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K190866
Methodology: https://510kreport.com/methodology