FDA 510(k)

Butterfly iQ Ultrasound System

K-Number: K202406 · 2020-09-16

Decision Date2020-09-16

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Butterfly iQ Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Butterfly Network, Inc.. It received FDA 510(k) clearance on 2020-09-16 under 510(k) number K202406. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Butterfly iQ Ultrasound System?

Butterfly iQ Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-09-16. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K202406.

When did Butterfly iQ Ultrasound System receive FDA 510(k) clearance?

Butterfly iQ Ultrasound System received FDA 510(k) clearance on 2020-09-16, under 510(k) number K202406.

Who is the listed applicant for Butterfly iQ Ultrasound System?

The FDA 510(k) record lists Butterfly Network, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Butterfly iQ Ultrasound System?

The FDA product code for Butterfly iQ Ultrasound System is IYN.

Other records listing Butterfly Network, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252148Butterfly Gestational Age Tool K232808Butterfly iQ3 Ultrasound System K220068Butterfly iQ/iQ+ Ultrasound System K200980Auto 3D Bladder Volume Tool K163510Poseidon Ultrasound System

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.