# K041761: Rapidiacolon

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Jul 13, 2004 after 13 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: 3 generations back to K954678 (1996). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.

## Most influential descendants
- K082990: Infinitt Xelis (2008), 6 descendants of its own
- 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

## Indications for use
RapidiaColon TM is a software application for the display and 3D visualization of medical data derived from CT and MRI scanners. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware

Source page: https://510kreport.com/device/K041761
Methodology: https://510kreport.com/methodology