# K981958: Leisegang Video Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Netoptix Corp.
- Decided: Oct 19, 1998 after 137 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 K940094 (1995). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940094: Colposcopes and Accessories, Leisegang Medical, Inc. (1995) Summary page 1.
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 1.

## Most influential descendants
- K021854: DFV CPG Colposcope (2002), 4 descendants of its own
- K140754: Cooper Surgical Leisegang Colposcope System (2014), 1 descendant of its own
- K070845: Sounmed Coloposcope Colpo-99/99PLUS (2007), 1 descendant of its own
- K160341: Colposcope System (2016), 0 descendants of its own
- K101141: Seiler Colposcope, Models 935, 955 and 985 (2010), 0 descendants of its own

## Indications for use
The Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

Source page: https://510kreport.com/device/K981958
Methodology: https://510kreport.com/methodology