510(k) · Radiology

Auto 3D Bladder Volume Tool

by Butterfly Network, Inc.

Auto 3D Bladder Volume Tool is an AI-enabled medical device from Butterfly Network, Inc. that the U.S. FDA cleared through 510(k) K200980 on June 11, 2020. Its lead review panel is Radiology and its primary product code is IYO (System, Imaging, Pulsed Echo, Ultrasonic).

See also FDA-cleared AI radiology devices in 2020, all FDA AI clearances in 2020, top radiology AI devices.

Key facts

Submission numberK200980
Pathway510(k)
Date of final decision
Company (FDA list)Butterfly Network, Inc.
Lead review panelRadiology
Primary product codeIYO — System, Imaging, Pulsed Echo, Ultrasonic
Applicant (openFDA)Butterfly Network, Inc.
Applicant locationGuildford, CT, US
Device classClass 2
Regulation number21 CFR 892.1560
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Auto 3D Bladder Volume Tool went through this pathway (K200980).

openFDA lists it as a Class 2 device under 21 CFR 892.1560. Class II devices are moderate risk and are subject to general and special controls.

Product code IYO covers 12 devices on the FDA AI list. By decision date, this device is #3 of 12 under that code. Butterfly Network, Inc. has 4 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code IYO)

More from Butterfly Network, Inc.