Butterfly iQ3 Ultrasound System

Primary DI

00850027593029

Basic UDI-DI Code

00850027593029E4

Reference

850-20026-XX

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Butterfly Network, Inc.

The Butterfly iQ3 Ultrasound System consists of a single transducer with broad imaging capabilities connected via a USB cable to a handheld commercial off the shelf (COTS) mobile device with the Butterfly iQ App downloaded. The user interface (App) includes touch screen menus, buttons, controls, indicators and navigation icons that allow the operator to control the system and to view and measure ultrasound imagery. The Butterfly iQ3 Ultrasound is intended to use by by a trained healthcare professional enabling diagnostic imaging, measurement of anatomical structures and fluid, and other applicable tools.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDR).