# K191541: Vave Personal Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Vave Health, Inc.
- Decided: Jul 10, 2019 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: 16 generations back to K935595 (1995). 127 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140693: Vscan with Dual Probe, Ge Medical Sysyems Ultrasound & Primary Care Diagn (2014) Summary page 7.

## Most influential descendants
- K241051: Vave Wireless Ultrasound System (2024), 0 descendants of its own

## Indications for use
The Vave Personal Ultrasound is intended for diagnostic ultrasound imaging in B-Mode. It is indicated for diagnostic ultrasound imaging in the following applications: Fetal/Obstetric, Abdominal (includes Gynecology, Renal, and Urology), Pediatric, Thoracic/Pleural, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel and procedural guidance of needles into the body. The Vave Personal Ultrasound is a transportable ultrasound system intended for use in environments where healthcare is provided by healthcare professionals.

Source page: https://510kreport.com/device/K191541
Methodology: https://510kreport.com/methodology