# K232808: Butterfly iQ3 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Butterfly Network, Inc.
- Decided: Jan 4, 2024 after 114 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: 25 generations back to K935595 (1995). 277 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 279 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220068: Butterfly iQ/iQ+ Ultrasound System, Butterfly Network, Inc. (2023) Summary page 5.

## Most influential descendants
- K252148: Butterfly Gestational Age Tool (2026), 0 descendants of its own

## Indications for use
The iQ3 Ultrasound System is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, Lung, Procedural Guidance, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include B-mode, B-mode + M-mode, B-mode + Color Doppler, B-mode + Power Doppler, Spectral Pulsed Wave Doppler, Fetal Heart Sounds, B-mode + Biplane, B-mode + Needle Viz Tool, B-mode + Biplane+ Needle Viz Tool, B-mode + Multi-Slice, and B-mode + Sweep. The Butterfly iQ3 Ultrasound System's portability and user interface enables integration into professional healthcare facilities (e.g. Hospital, clinic, hospice, or medical office), home healthcare environment, ambulances and/or accident sites, and other environments where healthcare is provided. Users may also include medical students working under the supervision or authority of a physician during their education/training.

Source page: https://510kreport.com/device/K232808
Methodology: https://510kreport.com/methodology