# K042674: Colon Car 1.2

- Pathway: 510(k) (Special)
- Applicant: Medicsight
- Decided: Oct 19, 2004 after 20 days
- Product code: NWE (Colon Computed Tomography System, Computer Aided Detection)
- 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: 4 generations back to K954355 (1995). 9 ancestors in all.
209 later devices descend from it; 3 cite 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)
- K033102: Medic Colon Model, Release 1, Medicsight (2003) Summary page 1.

## Most influential descendants
- 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
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own

## Indications for use
Colon CAR 1.2 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 single or double seed points followed by interactive fine-tuning the boundaries of the ROI. It also allows for the simultaneous display of supine and prone images. Colon CAR 1.2 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.

Source page: https://510kreport.com/device/K042674
Methodology: https://510kreport.com/methodology