# K042605: Colongraphy Software Package with Extended Functionality

- Pathway: 510(k) (Special)
- Applicant: Siemens AG Medical Solutions
- Decided: Oct 8, 2004 after 14 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: 3 generations back to K954355 (1995). 7 ancestors in all.
76 later devices descend from it; 4 cite it directly.
0 of 84 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 2.

## Most influential descendants
- 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
- K163691: HS70A Diagnostic Ultrasound System (2017), 58 descendants of its own
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own

## Indications for use
syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT or MR scanning.

Source page: https://510kreport.com/device/K042605
Methodology: https://510kreport.com/methodology