FDA Registration
Active
🇺🇸 United States
Butterfly iQ/iQ+ Ultrasound System
Reg #: 3010102386
·
FEI: 3010102386
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- BUTTERFLY NETWORK, INC.
- Registration Number
- 3010102386
- FEI Number
- 3010102386
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1600 District Ave
- City
- Burlington
- State
- MA
- ZIP
- 01803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220068
Owner / Operator
- Firm Name
- Butterfly Network, Inc.
- Operator Number
- 10057531
- Address
- 1600 District Ave
- City
- Burlington
- State
- MA
- Postal Code
- 01803
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2023-09-26 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2023-09-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-09-26 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-09-26 |
Proprietary Names
Butterfly iQ/iQ+ Ultrasound System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device