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Butterfly Network, Inc.

United States·US-MF-000008565

Last updated September 17, 2026

About

Welcome to connected medicine. Butterfly brings the power of ultrasound into your assessment, diagnosis and treatment process. One probe. Whole-body imaging. For any medical system.

From the manufacturer's own website. Source

Information

Country: United States
Address: 1600, District Avenue, Burlington, United States
Website: www.butterflynetwork.com
LinkedIn: linkedin.com/company/2338924
Facebook: facebook.com/butterflynetinc
Email: [email protected]
Phone: —
PRRC Contact: Scott Derrickson
EUDAMED SRN: US-MF-000008565
FDA FEI Number: 3010102386
DUNS Number: —

Catalogue (26)

Device	Model / Reference	Registries	Class	Status
USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter	490-00192-02	FDA UDI	Class II	Active
Butterfly Iq3 Accessory Cable, Usb-C, Usb2.0, 2.50m	490-00228-03	FDA UDI	Class II	Active
Butterfly iQ3 Charger Kit	815-20054-00	FDA UDI	Class II	Active
USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter	490-00187-03	FDA UDI	Class II	Active
Butterfly Mobile Device Charging Kit	815-20072-00	FDA UDI	Class II	Active
USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter	490-00187-00	FDA UDI	Class II	Active
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter	490-00183-02, 490-00189-02	FDA UDI	Class II	Active
USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter	490-00187-02	FDA UDI	Class II	Active
BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT	WTD1A05	FDA UDI	Class II	Active
Butterfly Iq3 Accessory Cable, Lightning C78, Usb2.0, 2.50m	490-00227-03	FDA UDI	Class II	Active
LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter	490-00189-03	FDA UDI	Class II	Active
Butterfly iQ3 Charger Kit	815-20054-01	FDA UDI	Class II	Active
Butterfly iQ3 Ultrasound System	850-20026	FDA UDI	Class II	Active
LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter	490-00183-01, 490-00189-01	FDA UDI	Class II	Active
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter	490-00183-00, 490-00189-00	FDA UDI	Class II	Active
Butterfly Iq3 Accessory Cable, Lightning C78, Usb2.0, 1.50m	490-00227-02	FDA UDI	Class II	Active
Butterfly Iq3 Accessory Cable, Usb-C, Usb2.0, 1.50m	490-00228-02	FDA UDI	Class II	Active
USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter	490-00187-01	FDA UDI	Class II	Active
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter	490-00183-02, 490-00189-02	FDA UDI	Class II	Unknown
Poseidon Ultrasound System	K163510	FDA 510(k)	Class II	Active
Butterfly iQ3 Ultrasound System	K232808	FDA 510(k)	Class II	Active
Auto 3D Bladder Volume Tool	K200980	FDA 510(k)	Class II	Active
Butterfly Gestational Age Tool	K252148	FDA 510(k)	Class II	Active
Butterfly iQ+ Ultrasound System	850-20014	EUDAMEDFDA UDI	Class IIa	Active
Butterfly iQ+ Bladder Ultrasound System	850-20028-XX	EUDAMEDFDA UDI	Class IIa	Active
Butterfly iQ Ultrasound System	850-20003	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 24, 2020	Z-1600-2020	—	terminated	Distributed without an approved 510(k)
Feb 24, 2020	Z-1601-2020	—	terminated	Distributed without an approved 510(k)