# K110147: Ultrasighthd C31 with Imagesense and Remote Viewer Telemedicine

- Pathway: 510(k) (Traditional)
- Applicant: Sti Medical Systems, LLC
- Decided: Apr 8, 2011 after 80 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955635 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090324: Ultrasight HD Digital Colposcopy with Imagesense Technology, Sti Medical Systems (2010) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K110147
Methodology: https://510kreport.com/methodology