# K211623: THD Procto Software System

- Pathway: 510(k) (Special)
- Applicant: Thd Spa
- Decided: Jun 24, 2021 after 29 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: 6 generations back to K931574 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193512: THD Procto Software System, Thd Spa (2020) Summary page 5.
- K180135: THD Anopress with THD SensyProbe, Thd Spa (2018) Summary page 5.

## Indications for use
The THD Procto Software System is 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 an adequate resolution and their subsequent processing. * In anorectal manometry examinations, in order to view on a two-dimensional Pressure/Time graph the acquisition of the mean pressure signal transmitted by the THD Anopress device and subsequent processing (examination report and report printing) * Follow the clinical history, possible follow-ups of a patients

Source page: https://510kreport.com/device/K211623
Methodology: https://510kreport.com/methodology