FDA Registration
Active
🇰🇷 South Korea
Acuson SC2000 Diagnostic Ultrasound System
Reg #: 3006985147
·
FEI: 3006985147
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Siemens Healthineers Ltd.
- Registration Number
- 3006985147
- FEI Number
- 3006985147
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2nd & 3rd Venture Building, Pohang Technopark, 394, Jigok-ro, Nam-gu
- City
- Pohang-si Gyeongbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K162221
Owner / Operator
- Firm Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Operator Number
- 9002915
- Address
- 40 Liberty Boulevard
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
US Agent
- Business Name
- Siemens Medical Solutions USA, Inc.
- Contact Name
- Zhengbin Xu
- Address
- 22010 SE 51 Street
- City
- Issaquah
- State
- WA
- ZIP
- 98029
- Country
- US
- [email protected]
- Phone
- 425 2418272
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2017-04-10 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2017-04-10 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2017-04-10 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2017-04-10 |
Proprietary Names
Acuson SC2000 Diagnostic Ultrasound System
Establishment Types
Manufacture Medical Device