Butterfly Network, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1600-2020 | Class II | Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentati | February 24, 2020 |
| Z-1601-2020 | Class II | Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 | February 24, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232808 | Butterfly iQ3 Ultrasound System | January 4, 2024 |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | March 31, 2023 |
| K202406 | Butterfly iQ Ultrasound System | September 16, 2020 |
| K200980 | Auto 3D Bladder Volume Tool | June 11, 2020 |
| K163510 | Poseidon Ultrasound System | September 6, 2017 |