Identity
- Trade Name
- BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT FDA UDI
- Model / Reference
- WTD1A05 FDA UDI
- Description
- BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866646000268 FDA UDI
- 510(k) Number
- K163510 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand-held ultrasound imaging system, body-surface
BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT by Butterfly Network, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hand-held ultrasound imaging system, body-surface.
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- GUI — Sonivate Medical, Inc. · Class II
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- Terason — Teratech Corporation · Class II
Cleared under the same submission
K163510 also covers:
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter — Butterfly Network, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Butterfly Network, Inc.
Sources (1)
- FDA UDI e14a8d17-58a9-4167-b94d-2d91c5308a76 35 fields · synced Jun 9, 2026