Butterfly iQ3 Ultrasound System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232808 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Butterfly iQ3 Ultrasound System is a portable, handheld ultrasound device designed for real-time imaging of soft tissues and organs. It employs advanced micro-ultrasound technology to provide high-resolution, high-frequency imaging, enabling clinicians to perform rapid assessments without the need for traditional ultrasound transducers or gel applications.
This system is intended for single-use applications in clinical settings, including emergency, surgical, and diagnostic environments. Supplied sterile and pre-sterilized, it is classified under the MDR and holds FDA 510(k) clearance (K232808) as substantially equivalent to a predicate device. The device is MRI-safe and available in a compact, portable form factor for immediate use at the point of care.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232808 | Class II | Active |
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Manufacturer
- Manufacturer
- Butterfly Network, Inc.
Sources (2)
- FDA 510(k) K232808 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026