# K193512: THD Procto Software System

- Pathway: 510(k) (Traditional)
- Applicant: Thd Spa
- Decided: Jan 26, 2020 after 39 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K081781 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140899: Halo Medical Technologies Catalyst Midcrystl Halo Ultrasound System, Halo Medical Technologies, LLC (2014) Summary page 4.

## Most influential descendants
- K211623: THD Procto Software System (2021), 0 descendants of its own

## Indications for use
The THD Procto Software 1is a software that can be used: * In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image. * In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol

Source page: https://510kreport.com/device/K193512
Methodology: https://510kreport.com/methodology