# K081781: NUWAV

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies, Corp.
- Decided: Jul 9, 2008 after 15 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
No predicates in its family tree.
3 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K140899: Halo Medical Technologies Catalyst Midcrystl Halo Ultrasound System (2014), 2 descendants of its own
- 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
The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

Source page: https://510kreport.com/device/K081781
Methodology: https://510kreport.com/methodology