510(k) · Cleared
ClearedDYSIS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forth Photonics Hellas SA · HEX Colposcope (And Colpomicroscope)
Cleared on Mar 10, 2011 as substantially equivalent to K955635 (Welch Allyn, Inc., 1996) and 2 other predicates after a 580-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 10, 2011
- Review
- 580 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K940094 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
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 | K972630 | Coopersurgical Digital Colposcopy System | CooperSurgical, Inc. | 1998 | — |
| 0 (this device) | K092433 | DYSIS | Forth Photonics Hellas SA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm StandSummary page 1…r Model Trade Name 510(k) Welch-Allyn 88000/8900 Video Colposcope K955635 Cooper Surgical CooperSurgical Digital Colposcopy System K972630 Goidway SLC-20… | 1996 |
| * | K972630 | Coopersurgical Digital Colposcopy SystemSummary page 1…88000/8900 Video Colposcope K955635 Cooper Surgical CooperSurgical Digital Colposcopy System K972630 Goidway SLC-2000 Goidway Digital Video Colposcope Imaging K(021153 ______________ _____… | 1998 |
| * | K021153 | Goldway Digital Video Colposcope Imaging System, Model #SLC-2000Summary page 1…CooperSurgical Digital Colposcopy System K972630 Goidway SLC-2000 Goidway Digital Video Colposcope Imaging K(021153 ______________ ___________ System The indications for use for Forth Photonics DySIS digital colposcope are substan… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- None of the 5 ancestors has a recall.
- 7 other devices also cite its predicate K955635.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
DySIS with Pseudo-Color Imaging (PCI) is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. The PCI feature is an adjunctive tool for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092433: DYSIS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092433
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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