# K082990: Infinitt Xelis

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Nov 20, 2008 after 44 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: 5 generations back to K942120 (1994). 12 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041761: Rapidiacolon, Infinitt Co., Ltd. (2004) Summary page 1.
- K052545: Infinitt G3 Pacs, Infinitt Co., Ltd. (2005) Summary page 1.

## Most influential descendants
- K102684: Xelis Dental (2010), 2 descendants of its own
- K193369: Xelis Dental 2.0 (2020), 0 descendants of its own
- K151371: Corporate Dental Imaging (CDI) Application (2015), 0 descendants of its own
- K111660: Xelis Cardiac (2011), 0 descendants of its own
- K111613: Xelis Fusion (2011), 0 descendants of its own

## Indications for use
XELIS TM is a software based device (utilizing PC hardware) for the display and visualization of 3D and 2D medical image data of the colon. Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by Radiologists, Clinicians, and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

Source page: https://510kreport.com/device/K082990
Methodology: https://510kreport.com/methodology