# K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000

- Pathway: 510(k) (Traditional)
- Applicant: Goldway Us, Inc.
- Decided: Feb 10, 2003 after 306 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). 3 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000707: Leica Colposcope, Leica Microscopy Systems, Ltd. (2000) Summary page 2.
- K940094: Colposcopes and Accessories, Leisegang Medical, Inc. (1995) Summary page 2.
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 2.

## Most influential descendants
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope (2013), 7 descendants of its own
- K151878: Video Colposcope (2015), 2 descendants of its own
- K181034: Pocket Colposcope System (2018), 1 descendant of its own
- K161871: EVA (Enhanced Visual Assessment) System (2016), 1 descendant of its own
- K140754: Cooper Surgical Leisegang Colposcope System (2014), 1 descendant of its own

## Indications for use
The Goldway Digital Video Colposcope Imaging System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The imag,e system is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color screen, printed on a color printer or archived for storage and subsequent retrieval. The device is intended for use in Hospitals and clinics.

Source page: https://510kreport.com/device/K021153
Methodology: https://510kreport.com/methodology