# K030982: Syngo Colonography Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 8, 2003 after 11 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 2 generations back to K954355 (1995). 6 ancestors in all.
227 later devices descend from it; 5 cite it directly.
1 of 234 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012313: CT Colonography/NAVIGATOR2, Ge Medical Systems, Inc. (2001)
- K971717: Fly Through, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K973010: Realtime 3D Diagnostic Workstation, Siemens Medical Solutions USA, Inc. (1997) Summary page 2.
- K923524: Volumetric Rendering Technique Option, Siemens Medical Solutions USA, Inc. (1994) Summary page 2.
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001)

## Most influential descendants
- K033102: Medic Colon Model, Release 1 (2003), 210 descendants of its own
- 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
- K042605: Colongraphy Software Package with Extended Functionality (2004), 76 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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position. Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.

Source page: https://510kreport.com/device/K030982
Methodology: https://510kreport.com/methodology