510(k) · Cleared
ClearedUltrasighthd C31 with Imagesense and Remote Viewer Telemedicine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sti Medical Systems, LLC · HEX Colposcope (And Colpomicroscope)
Cleared on Apr 8, 2011 as substantially equivalent to K090324 (Sti Medical Systems, 2010) after an 80-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 8, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955635 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK955635 Video Colposcope/Vertical Rolling Base/Swing Arm StandWelch Allyn, Inc. · 1996
- 2 generations backK072691 Cervical MD, Model C10Sti Medical Systems · 2008
- 1 generation backK090324 Ultrasight HD Digital Colposcopy with Imagesense TechnologySti Medical Systems · 2010
- This deviceK110147 Ultrasighthd C31 with Imagesense and Remote Viewer TelemedicineSti Medical Systems, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955635 | Video Colposcope/Vertical Rolling Base/Swing Arm Stand | Welch Allyn, Inc. | 1996 | — |
| −2 | K072691 | Cervical MD, Model C10 | Sti Medical Systems | 2008 | — |
| −1 | K090324 | Ultrasight HD Digital Colposcopy with Imagesense Technology | Sti Medical Systems | 2010 | — |
| 0 (this device) | K110147 | Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine | Sti Medical Systems, LLC | 2011 | — |
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 |
|---|---|---|---|
| * | K090324 | Ultrasight HD Digital Colposcopy with Imagesense TechnologySummary page 1…tion Regulation: 21 CFR § 884.1630 Regulatory Class: Class 11 Product Code: HEX 3. Predicate Device(s): K090324, UltraSightHD (030) Digital Colposcopy System with ImageSense Technology, STI Medical Systems, December 20, 2010. 4… | 2010 |
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 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
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?
UltraSightHD C31 with ImageSense and Remote Viewer Telemedicine 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 is an ImageSense digital filter for displaying areas of acetowhitening. It is a tool that…
Read the full statement (109 words)
UltraSightHD C31 with ImageSense and Remote Viewer Telemedicine 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 is an ImageSense digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The Remote Viewer Telemedicine Technology is a software feature that enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110147 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110147: Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110147
Report an extraction error
Are you the manufacturer?
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