# K181034: Pocket Colposcope System

- Pathway: 510(k) (Traditional)
- Applicant: Hadleigh Health Technologies, LLC
- Decided: Sep 21, 2018 after 156 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: 3 generations back to K940094 (1995). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151878: Video Colposcope, Edan Instruments, Inc. (2015) Summary page 4.

## Most influential descendants
- K233043: Smart Scope® CX (2024), 0 descendants of its own

## Indications for use
The Pocket Colposcope is a digital video colposcope intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The Pocket Colposcope System is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.

Source page: https://510kreport.com/device/K181034
Methodology: https://510kreport.com/methodology