# K202406: Butterfly iQ Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Butterfly Network, Inc.
- Decided: Sep 16, 2020 after 26 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: 23 generations back to K935595 (1995). 275 ancestors in all.
5 later devices descend from it; 2 cite it directly.
6 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163510: Poseidon Ultrasound System, Butterfly Network, Inc. (2017) Summary page 5.
- K170714: Venue, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2017) Summary page 5.

## Most influential descendants
- K220068: Butterfly iQ/iQ+ Ultrasound System (2023), 2 descendants of its own
- K232808: Butterfly iQ3 Ultrasound System (2024), 1 descendant of its own
- K211527: Exo Iris (2021), 1 descendant of its own
- K252148: Butterfly Gestational Age Tool (2026), 0 descendants of its own
- K222198: Exo Iris  (El2001) (2022), 0 descendants of its own

## Indications for use
The Butterfly iQ Ultrasound System is indicated for use by trained healthcare professionals in environments where healthcare is provided 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), Procedural Guidance, Small Organs (including thyroid, scrotum and breast), Cardiac, Abdominal, 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.

Source page: https://510kreport.com/device/K202406
Methodology: https://510kreport.com/methodology