# K033870: Image Management System

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Mar 12, 2004 after 91 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- 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 K000411 (2000). 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)
- K000411: Chili Video, Chili Videopro, Steinbeis-Transferzentrum Medizinische Informatik (2000) Summary page 1.

## Indications for use
The Welch Allyn Basic Image Management system is intended to capture, display, save, export, and print images obtained from the Welch Allyn video colposcope. The images captured, displayed, saved, exported, and printed from the Basic Image Management system/are not intended for diagnostic purposes. The provider shall use the image on the :olposcope monitor for clinical diagnosis.

Source page: https://510kreport.com/device/K033870
Methodology: https://510kreport.com/methodology