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Butterfly iQ Ultrasound System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 850-20003
Identity
- Trade Name
- Butterfly iQ Ultrasound System EUDAMEDButterfly Network, Inc. FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Butterfly iQ Ultrasound System EUDAMEDPortable Ultrasound System FDA UDI
- Model / Reference
- 850-20003 EUDAMEDButterfly iQ FDA UDI
- Description
- Portable Ultrasound System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866646000206 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00866646000206 EUDAMED
- 510(k) Number
- K163510 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Butterfly iQ Ultrasound System by Butterfly Network, Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202406 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220068 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00866646000206 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Butterfly Network, Inc.
- EUDAMED SRN
- US-MF-000008565
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 5c61db97-a3c0-4639-a29a-0b8a057296b9 61 fields · synced Jul 21, 2026
- FDA UDI 05f5f3b5-1366-4fc9-b7e0-cbd4c93f4764 35 fields · synced May 29, 2026
- FDA 510(k) K202406 1 fields · synced May 18, 2026