# K102949: Colonoscopy Assistant

- Pathway: 510(k) (Traditional)
- Applicant: Sti Medical Systems, LLC
- Decided: Jun 15, 2011 after 253 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K924178 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043324: Aida with Dicom and HL7 Interface, KARL STORZ Endoscopy-America, Inc. (2005) Summary page 1.

## Indications for use
This software is an accessory to standard colonoscopy. It is intended for use in the viewing, recording, archival, localization, documentation, and retrieval of still images, video, and patient data during and after a standard colonoscopic procedure. Standard colonoscopy is indicated for the evaluation of results from an abnormality on barium enema or other imaging study, unexplained gastrointestinal bleeding, screening and surveillance for colonic neoplasia, the excision of a colonic polyp, or the management of chronic inflammatory bowel disease. Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.

Source page: https://510kreport.com/device/K102949
Methodology: https://510kreport.com/methodology