Identity
- Trade Name
- Butterfly iQ3 Charger Kit FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Model / Reference
- 815-20054-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027593074 FDA UDI
- 510(k) Number
- K232808 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX 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 UDI892.1560 FDA UDI892.1570 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
No
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 iQ3 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
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
- Terason — Teratech Corporation · Class II
Cleared under the same submission
K232808 also covers:
- BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 1.50M — Butterfly Network, Inc.
- BUTTERFLY IQ3 ACCESSORY CABLE, LIGHTNING C78, USB2.0, 2.50M — Butterfly Network, Inc.
- BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 1.50M — Butterfly Network, Inc.
- BUTTERFLY IQ3 ACCESSORY CABLE, USB-C, USB2.0, 2.50M — Butterfly Network, Inc.
- Butterfly iQ3 Charger Kit — Butterfly Network, Inc.
- Butterfly iQ3 Ultrasound System — 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 15720d0f-cce3-4214-8e02-0a134cd3e7e2 33 fields · synced Jun 9, 2026