Devices · Butterfly Network, Inc.

Auto 3D Bladder Volume Tool

Butterfly Network, Inc. is listed for Auto 3D Bladder Volume Tool (K200980). The FDA list gives June 11, 2020 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYO. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K200980

Official FDA database record

Date of final decision

June 11, 2020

Company on the FDA list

Butterfly Network, Inc.

Lead panel

Radiology

Primary product code

IYO

openFDA device name for the code

System, Imaging, Pulsed Echo, Ultrasonic

Device class

2

Regulation number

892.1560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary