510(k) · Cleared
ClearedUltrasight HD Digital Colposcopy with Imagesense Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sti Medical Systems · HEX Colposcope (And Colpomicroscope)
Cleared on Dec 20, 2010 as substantially equivalent to K072691 (Sti Medical Systems, 2008) after a 679-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Dec 20, 2010
- Review
- 679 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955635 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955635 Video Colposcope/Vertical Rolling Base/Swing Arm StandWelch Allyn, Inc. · 1996
- 1 generation backK072691 Cervical MD, Model C10Sti Medical Systems · 2008
- This deviceK090324 Ultrasight HD Digital Colposcopy with Imagesense TechnologySti Medical Systems · 2010
- Descendant · cites it directly · 0 of its ownK110147 Ultrasighthd C31 with Imagesense and Remote Viewer TelemedicineSti Medical Systems, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K110147Ultrasighthd C31 with Imagesense and Remote Viewer TelemedicineSti Medical Systems, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm Stand | Welch Allyn, Inc. | 1996 | — |
| −1 | K072691 | Cervical MD, Model C10 | Sti Medical Systems | 2008 | — |
| 0 (this device) | K090324 | Ultrasight HD Digital Colposcopy with Imagesense Technology | Sti Medical Systems | 2010 | — |
| +1 | K110147 | Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine | Sti Medical Systems, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K072691 | Cervical MD, Model C10Summary page 1…that should NOT. be used as a substitute for a thorough colposcopic evaluation. Predicate Device The predicate device is the Cervical MID Model C10, STI Medical Systems, K072691, January 31, 2008. The proposed device differs from the predicate with respect to the addition of new imaging features referred t… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110147 | Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine | 2011 | 0 |
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 14 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110147 (Sti Medical Systems, LLC, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
UltraSightHD TM with ImageSense TM 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.
OpacityViewer TM is an ImageSense Tm digital filter 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/K090324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090324: Ultrasight HD Digital Colposcopy with Imagesense Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090324
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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