FDA Registration
Active
🇰🇷 South Korea
ACUSON S3000 Diagnostic Ultrasound System
Reg #: 3006985147
·
FEI: 3006985147
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
2
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
- K172162
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 | 2017-09-06 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2017-09-06 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2017-09-06 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2017-09-06 |
Proprietary Names
ACUSON S3000 Diagnostic Ultrasound System
ACUSON S2000 Diagnostic Ultrasound System
ACUSON S1000 Diagnostic Ultrasound System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device