# K061532: Gentle Colon (Revision 2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Rendoscopy, Inc.
- Decided: Sep 18, 2006 after 108 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: 1 generation back to K954355 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954355: Advantage Windows 3D with Navigator Option, General Electric Co. (1995) Summary page 1.

## Indications for use
Rendoscopy's Gentle Colon, revision 2.0, is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM compliant CT scans for the purpose of complete colonic mucosa assessment. The user is capable to assure the colonic mucosa image quality through the following provisions built into the software: * 3D visualization (3D detection, 2D assessment) * No blind areas behind colonic folds due to splitting colon techniques * Multi-path tracking system allows path finding over collapsed or liquid-filled parts of the colon * The software provides full presentation of cross sectional imaging, such as axial, sagittal, frontal, oblique, intra-luminal, split colon, topogram view, external and unrolled view of the colon and double contrast visualization It also includes an automatic report creation facility and is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image study reports utilizing PC hardware. The target population of the Gentle Colon 3D application is the adult patient. It is intended to be used as adjunctive to standard radiology practices for diagnosis, such as the double contrast/barium enema, of the colon.

Source page: https://510kreport.com/device/K061532
Methodology: https://510kreport.com/methodology