FDA 510(k)

Butterfly iQ/iQ+ Ultrasound System

K-Number: K220068 · 2023-03-31

Decision Date2023-03-31

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Butterfly iQ/iQ+ Ultrasound System is a medical device manufactured by Butterfly Network, Inc.. It received FDA 510(k) clearance on 2023-03-31 under approval number K220068. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Butterfly iQ/iQ+ Ultrasound System?

Butterfly iQ/iQ+ Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-03-31. It is manufactured by Butterfly Network, Inc.. The 510(k) number is K220068.

When was Butterfly iQ/iQ+ Ultrasound System approved by the FDA?

Butterfly iQ/iQ+ Ultrasound System received FDA 510(k) clearance on 2023-03-31, under approval number K220068.

What company makes Butterfly iQ/iQ+ Ultrasound System?

Butterfly iQ/iQ+ Ultrasound System is manufactured by Butterfly Network, Inc..

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

The FDA product code for Butterfly iQ/iQ+ Ultrasound System is IYO.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT06559891 THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Other Devices by Butterfly Network, Inc.

K163510Poseidon Ultrasound System K202406Butterfly iQ Ultrasound System K200980Auto 3D Bladder Volume Tool K232808Butterfly iQ3 Ultrasound System K252148Butterfly Gestational Age Tool

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

View on FDA Database →

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