510(k) · Cleared
ClearedGoldway Digital Video Colposcope Imaging System, Model #SLC-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Goldway Us, Inc. · HEX Colposcope (And Colpomicroscope)
Cleared on Feb 10, 2003 as substantially equivalent to K000707 (Leica Microscopy Systems, Ltd., 2000) and 2 other predicates after a 306-day review. Its family tree reaches back 1 generation to 1995. 13 later devices descend from it.
- Decided
- Feb 10, 2003
- Review
- 306 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K940094 (1995). 3 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- This deviceK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- Descendant · cites it directly · 7 of its ownK122973 AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK151878 Video ColposcopeEdan Instruments, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK181034 Pocket Colposcope SystemHadleigh Health Technologies, LLC · 2018
- Descendant · 2 generations on · 1 of its ownK161871 EVA (Enhanced Visual Assessment) SystemMobileodt, Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK140754 Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K122973AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013 · cites it directly7descendants
- K151878Video ColposcopeEdan Instruments, Inc. · 2015 · cites it directly2descendants
- K181034Pocket Colposcope SystemHadleigh Health Technologies, LLC · 2018 · 2 generations on1descendant
- K161871EVA (Enhanced Visual Assessment) SystemMobileodt, Ltd. · 2016 · 2 generations on1descendant
- K140754Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| 0 (this device) | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| +1 | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope | Medgyn Products, Inc. | 2013 | — |
| +1 | K151878 | Video Colposcope | Edan Instruments, Inc. | 2015 | — |
| +2 | K181034 | Pocket Colposcope System | Hadleigh Health Technologies, LLC | 2018 | — |
| +2 | K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt, Ltd. | 2016 | — |
| +2 | K140754 | Cooper Surgical Leisegang Colposcope System | CooperSurgical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HEX device
- #1 K233043 Smart Scope® CXscore 8.4 · 4 generations · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000707 | Leica ColposcopeSummary page 2…icate Device Information Identification of Legally Markted Device Which We Claim Substantial Equivalence (Predicate Device): 1. Leica Colposcopes, MS-5 and MZ-6, K#000707, Leica Microscopy Systems Ltd., Depew, New York. 2. Leisegang Video Colposcope (LMZ), K#940094, Leisegang Medical, Inc… | 2000 |
| * | K940094 | Colposcopes and AccessoriesSummary page 2…(Predicate Device): 1. Leica Colposcopes, MS-5 and MZ-6, K#000707, Leica Microscopy Systems Ltd., Depew, New York. 2. Leisegang Video Colposcope (LMZ), K#940094, Leisegang Medical, Inc., Boca Raton, Florida 3. Welch Allyn Video Colposcope, 88000 and 89000, K#955635, Welch Allyn,… | 1995 |
| * | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandSummary page 2…New York. 2. Leisegang Video Colposcope (LMZ), K#940094, Leisegang Medical, Inc., Boca Raton, Florida 3. Welch Allyn Video Colposcope, 88000 and 89000, K#955635, Welch Allyn, Inc. 10-2 4. Device… | 1996 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HEX
165in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEX
No recall names HEX since 2007.
Adverse event reports per year · HEX
1in 2025
MAUDE reports naming product code HEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 129 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 211 | 0 | 2 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 165 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021153 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021153: Goldway Digital Video Colposcope Imaging System, Model #SLC-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021153
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026