# K111660: Xelis Cardiac

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Sep 13, 2011 after 91 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 Cardiac™ is intended for the manipulation, displaying, and distribution of medical images. It can display images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device is used by physicians when doing preoperative planning and post-operative follow-up. Device functions are initiated manually by the user and are not performed automatically or semi-automatically by the software. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not by the software. Typical users of this system are trained professionals, (for example: surgeons, physicians, and radiologists). This product is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Source page: https://510kreport.com/device/K111660
Methodology: https://510kreport.com/methodology