# K083423: Coloncad Api 3.1

- Pathway: 510(k) (Traditional)
- Applicant: Medicsight Plc
- Decided: May 17, 2011 after 909 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: 5 generations back to K954355 (1995). 11 ancestors in all.
70 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042674: Colon Car 1.2, Medicsight (2004) Summary page 3.
- K042605: Colongraphy Software Package with Extended Functionality, Siemens AG Medical Solutions (2004) Summary page 2.

## Most influential descendants
- K122536: Amcad-UT Detection Model 2.0 (2013), 69 descendants of its own
- K162094: RS80A Diagnostic Ultrasound System (2016), 64 descendants of its own
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K171070: WS80A Diagnostic Ultrasound System (2017), 42 descendants of its own

## Indications for use
Medicsight ColonCAD™ API is a non-invasive computer aided detection (CAD) image analysis software tool designed to assist radiologists in the detection of colorectal polyps during their review of digital images derived from CT colonography (CTC). This CAD software post-processes the CTC image data obtained from multi-detector computed tomography (MDCT) scanners. The device is intended to be used on patients referred for a CT Colonography examination, as an overlay tool to prompt the radiologist to colonic findings that have been identified by the device. The CAD can assist radiologists after they have made an initial review of all the CTC image data, supporting their evaluation ("second read").

Source page: https://510kreport.com/device/K083423
Methodology: https://510kreport.com/methodology