# K090220: Colon View, Model CSCV-001A

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Feb 11, 2009 after 13 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: 4 generations back to K954355 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041270: CT Colonography II, General Electric Medical Systems (2004) Summary page 1.
- K023943: CT Colonography, Ge Medical Systems, Inc. (2003) Summary page 1.
- K042605: Colongraphy Software Package with Extended Functionality, Siemens AG Medical Solutions (2004) Summary page 1.
- K030982: Syngo Colonography Software Package, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.

## Indications for use
This application software is an image analysis package that allows for the visualization of the colon using volume datasets that provide 2D, 3D and MPR images. When employed by a qualified physician, this package can be used to observe polyps, masses and other lesions of the colon. Upon observation of the potential lesion the physician can mark and categorize the observed lesion. This package also allows for the generation of reports that can be exported to DICOM based PACS systems for the continued tracking of changes in the colon.

Source page: https://510kreport.com/device/K090220
Methodology: https://510kreport.com/methodology