# K103130: Xelis 3D

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Jul 28, 2011 after 279 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: 6 generations back to K942120 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082990: Infinitt Xelis, Infinitt Co., Ltd. (2008) Summary page 1.
- K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion, Barcoview Mis Edinburgh (2007) Summary page 1.

## Indications for use
Xelis 3D is a software device intended for viewing of images acquired from various imaging modalities; CT, MR, CR, DR, US, PET and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mamnmographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mamnmographic images should only be viewed with a monitor approved by FDA for viewing mamnmographic images. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.

Source page: https://510kreport.com/device/K103130
Methodology: https://510kreport.com/methodology