# K122311: GC-3000E Digital Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Goldcare Meditech Co., Ltd.
- Decided: Sep 18, 2013 after 413 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000, Goldway Us, Inc. (2003) Summary page 1.

## Indications for use
The GC-3000E Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics.

Source page: https://510kreport.com/device/K122311
Methodology: https://510kreport.com/methodology