FDA 510(k)

Butterfly iQ3 Ultrasound System

K-Number: K232808 · 2024-01-04

Decision Date2024-01-04

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Butterfly iQ3 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 2024-01-04 under 510(k) number K232808. 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 iQ3 Ultrasound System?

Butterfly iQ3 Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K232808.

When did Butterfly iQ3 Ultrasound System receive FDA 510(k) clearance?

Butterfly iQ3 Ultrasound System received FDA 510(k) clearance on 2024-01-04, under 510(k) number K232808.

Who is the listed applicant for Butterfly iQ3 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 iQ3 Ultrasound System?

The FDA product code for Butterfly iQ3 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 K220068Butterfly iQ/iQ+ Ultrasound System K202406Butterfly 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.