# K140899: Halo Medical Technologies Catalyst Midcrystl Halo Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Halo Medical Technologies, LLC
- Decided: May 5, 2014 after 27 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: 1 generation back to K081781 (2008). 1 ancestor in all.
2 later devices descend 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)
- K081781: NUWAV, Laborie Medical Technologies, Corp. (2008) Summary page 2.

## Most influential descendants
- K193512: THD Procto Software System (2020), 1 descendant of its own
- K211623: THD Procto Software System (2021), 0 descendants of its own

## Indications for use
"Catalyst" is a diagnostic ultrasound system designed to be used for investigating disorders of the pelvic floor. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. MidCRYSTL and HALO probes allow for ultrasonography of the following: 1) on the surface of the perinetum and/or abdomen, 2) endocavity. by inserting the endovaginal probe into the vagina, and 3) endocavity, by inserting the endoanal probe into the anal canal.

Source page: https://510kreport.com/device/K140899
Methodology: https://510kreport.com/methodology