FDA Registration
Active
🇺🇸 United States
ACUSON S3000 Diagnostic Ultrasound System
Reg #: 3023245
·
FEI: 3023245
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Registration Number
- 3023245
- FEI Number
- 3023245
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 22010 S.E. 51ST ST.
- City
- ISSAQUAH
- State
- WA
- ZIP
- 98029
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152369
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2015-10-12 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2015-10-12 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2015-10-12 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2015-10-12 |
Proprietary Names
ACUSON S3000 Diagnostic Ultrasound System
ACUSON Oxana Diagnostic Ultrasound System
ACUSON S1000 Diagnostic Ultrasound System
ACUSON S2000 Diagnostic Ultrasound System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility