# K061831: Medchannel HTS System

- Pathway: 510(k) (Traditional)
- Applicant: Medchannel, LLC
- Decided: Aug 7, 2006 after 40 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951449 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951449: Model KM-25, Koven Technology, Inc. (1996) Summary page 1.

## Most influential descendants
- K150718: Wi-3 HAL-RAR System (2015), 0 descendants of its own

## Indications for use
The HTS System is an adjunctive audio vessel landmarking aid for use during hemorrhoidal artery treatment. It is not recommended for fetal or ophthalmic use.

Source page: https://510kreport.com/device/K061831
Methodology: https://510kreport.com/methodology