# K102684: Xelis Dental

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Oct 1, 2010 after 14 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). 21 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070464: ONDEMAND3D, Cybermed, Inc. (2007) Summary page 1.
- K082990: Infinitt Xelis, Infinitt Co., Ltd. (2008)

## Most influential descendants
- K193369: Xelis Dental 2.0 (2020), 0 descendants of its own
- K151371: Corporate Dental Imaging (CDI) Application (2015), 0 descendants of its own

## Indications for use
Xelis DENTAL is a software device that is intended to provide tools for the reading and review of a DICOM compliant series of medical imagers which can be interpreted as representing a volume of data. These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data. Xelis DENTAL is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction). These tools are meant for the use of trained medical imaging professionals to aid in their reading and review of such data. Xelis DENTAL is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Source page: https://510kreport.com/device/K102684
Methodology: https://510kreport.com/methodology