# K033102: Medic Colon Model, Release 1

- Pathway: 510(k) (Traditional)
- Applicant: Medicsight
- Decided: Nov 5, 2003 after 37 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K954355 (1995). 8 ancestors in all.
210 later devices descend from it; 1 cites it directly.
1 of 219 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012072: Voxar VC, Model 1.0, Voxar Limited (2001)
- K030982: Syngo Colonography Software Package, Siemens Medical Solutions USA, Inc. (2003)

## Most influential descendants
- K042674: Colon Car 1.2 (2004), 209 descendants of its own
- K061214: Aquariusaps Server (2006), 134 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K083423: Coloncad Api 3.1 (2011), 70 descendants of its own
- K122536: Amcad-UT Detection Model 2.0 (2013), 69 descendants of its own

## Indications for use
MedicColon I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the colon derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of polyps, cancers and other lesions. The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting a seed point followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images

Source page: https://510kreport.com/device/K033102
Methodology: https://510kreport.com/methodology