FDA Registration
Active
🇺🇸 United States
Edge Ultrasound System
Reg #: 3032367
·
FEI: 3002087856
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- FUJIFILM SONOSITE,INC.
- Registration Number
- 3032367
- FEI Number
- 3002087856
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21919 30th Dr SE
- City
- BOTHELL
- State
- WA
- ZIP
- 98021
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113156
Owner / Operator
- Firm Name
- FUJIFILM CORPORATION
- Operator Number
- 8031568
- Address
- 26-30, Nishiazabu 2-chome
- City
- MINATO-KU
- State
- Tokyo
- Postal Code
- 106-8620
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2013-10-23 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2013-10-23 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2013-10-23 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2013-10-23 |
Proprietary Names
Edge Ultrasound System
Establishment Types
Manufacture Medical Device