# K091529: Icad Veralook CTC Cad Software

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Aug 4, 2010 after 439 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: 5 generations back to K954355 (1995). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 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 2.
- K042605: Colongraphy Software Package with Extended Functionality, Siemens AG Medical Solutions (2004) Summary page 2.

## Most influential descendants
- K173744: ProFuse CAD (2018), 1 descendant of its own
- K191278: Rsi-Mri+ (2019), 0 descendants of its own

## Indications for use
iCAD's VeraLookTM CTC CAD is intended to automatically detect potential polyps in CT Colonography exams. The, identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.

Source page: https://510kreport.com/device/K091529
Methodology: https://510kreport.com/methodology