# K092433: DYSIS

- Pathway: 510(k) (Traditional)
- Applicant: Forth Photonics Hellas SA
- Decided: Mar 10, 2011 after 580 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: 2 generations back to K940094 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 1.
- K972630: Coopersurgical Digital Colposcopy System, CooperSurgical, Inc. (1998) Summary page 1.
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000, Goldway Us, Inc. (2003) Summary page 1.

## Indications for use
DySIS with Pseudo-Color Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Source page: https://510kreport.com/device/K092433
Methodology: https://510kreport.com/methodology