# K191023: Dolphin/IQ, Dolphin/4D and Dolphin/MAX

- Pathway: 510(k) (Special)
- Applicant: Viasonix, Ltd.
- Decided: May 16, 2019 after 29 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: 5 generations back to K993939 (2000). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170859: Dolphin/IQ and Dolphin/4D, Viasonix, Ltd. (2017) Summary page 9.

## Most influential descendants
- K202742: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory (2021), 0 descendants of its own

## Indications for use
Dolphin/IQ, Dolphin/4D and Dolphin/MAX are medical Doppler devices intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin systems can be used in hospitals, clinics and physician offices Contraindications : The Dolphin is not intended to be used in fetal or neonatal applications. Note : The Dolphin is to be used only by trained medical personnel.

Source page: https://510kreport.com/device/K191023
Methodology: https://510kreport.com/methodology