4 devices · 1 company · 2020 to 2026
Butterfly Network, Inc.: AI-enabled devices on FDA's list
4 devices from Butterfly Network, Inc., 2020 to 2026, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Butterfly Network, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Butterfly Gestational Age ToolK252148 · 510(k) | Radiology | IYN | database entry | |
| Butterfly iQ3 Ultrasound SystemK232808 · 510(k) | Radiology | IYN | database entry | |
| Butterfly iQ/iQ+ Ultrasound SystemK220068 · 510(k) | Radiology | IYO | database entry | |
| Auto 3D Bladder Volume ToolK200980 · 510(k) | Radiology | IYO | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.