510(k) · Cleared
ClearedAL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medgyn Products, Inc. · HEX Colposcope (And Colpomicroscope)
Cleared on Jun 12, 2013 as substantially equivalent to K021153 (Goldway Us, Inc., 2003) after a 259-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.
- Decided
- Jun 12, 2013
- Review
- 259 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940094 (1995). 4 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK940094 Colposcopes and AccessoriesLeisegang Medical, Inc. · 1995
- 1 generation backK021153 Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Goldway Us, Inc. · 2003
- This deviceK122973 AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeMedgyn Products, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK161871 EVA (Enhanced Visual Assessment) SystemMobileodt, Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK140754 Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK202915 IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC · 2021
- Descendant · cites it directly · 0 of its ownK190187 Gynescope SystemIllumigyn, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK182764 Biop Digital ColposcopeBiop Medical, Ltd. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161871EVA (Enhanced Visual Assessment) SystemMobileodt, Ltd. · 2016 · cites it directly1descendant
- K140754Cooper Surgical Leisegang Colposcope SystemCooperSurgical, Inc. · 2014 · cites it directly1descendant
- K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLC · 2021 · 2 generations on0descendants
- K190187Gynescope SystemIllumigyn, Ltd. · 2019 · cites it directly0descendants
- K182764Biop Digital ColposcopeBiop Medical, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940094 | Colposcopes and Accessories | Leisegang Medical, Inc. | 1995 | — |
| −1 | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000 | Goldway Us, Inc. | 2003 | — |
| 0 (this device) | K122973 | AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope | Medgyn Products, Inc. | 2013 | — |
| +1 | K161871 | EVA (Enhanced Visual Assessment) System | Mobileodt, Ltd. | 2016 | — |
| +1 | K140754 | Cooper Surgical Leisegang Colposcope System | CooperSurgical, Inc. | 2014 | — |
| +2 | K202915 | IRIS Thermocoagulator and Digital Colposcope | Liger Medical, LLC | 2021 | — |
| +1 | K190187 | Gynescope System | Illumigyn, Ltd. | 2019 | — |
| +1 | K182764 | Biop Digital Colposcope | Biop Medical, Ltd. | 2018 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Summary page 1…Claim Substantial Equivalence (Predicate Device): ) The Goldway Digital Video Colposcope Imaging System, model number SL.C-2000, manufactured by Goldway, 510(k) number: K021153. Note that the Goldway Digital Video Colposcope Imaging System included an LCD screen for viewing the images from the colposcope… | 2003 |
What descends from it? (7)
5 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K161871 (Mobileodt, Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K021153.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
MedGyn's Digital Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The images from the Digital Video Colposcope are to be viewed on a color monitor. The Digital Video Colposcope is intended for use in hospitals, clinics, and doctor’s offices.
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/K122973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122973
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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