# K111758: Cadens (TM) Colon

- Pathway: 510(k) (Traditional)
- Applicant: Dog Microsystems, Inc.
- Decided: Feb 14, 2012 after 237 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: 7 generations back to K913770 (1991). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030982: Syngo Colonography Software Package, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K043333: VITREA2, Version 3.7 Medical Image Processing System, Vital Images, Inc. (2004) Summary page 1.
- K040126: Viatronix V3D Colon, Revision 1.3, Viatronix, Inc. (2004) Summary page 1.

## Indications for use
CADIENS'' Colon isa self-contained image analysis software package for evaluating CT volume datasets. Combining enhanced commercially available digital image processing tools with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-luminal view), the wall and the outside (extra-luminal view) of the colon. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue, with respect to their size, dimensions, shape and position. It is to be used only by trained and instructed health care professionals.

Source page: https://510kreport.com/device/K111758
Methodology: https://510kreport.com/methodology