FDA Registration
Active
🇺🇸 United States
ACUSON NX3 Diagnostic Ultrasound System
Reg #: 2531814
·
FEI: 3002626007
·
Expires 2025
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Siemens Medical Solutions USA, Inc.
- Registration Number
- 2531814
- FEI Number
- 3002626007
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5168 Campus Dr.
- City
- Plymouth Meeting
- State
- PA
- ZIP
- 19462
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202683
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 |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2020-11-03 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-11-03 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2020-11-03 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2020-11-03 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-11-03 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2020-11-03 |
Proprietary Names
ACUSON NX3 Diagnostic Ultrasound System
ACUSON Sequoia Diagnostic Ultrasound System
ACUSON S Family (S1000/ S2000 / S3000) Diagnostic Ultrasound System
ACUSON Freestyle Diagnostic Ultrasound System
ACUSON P500 Diagnostic Ultrasound System
ACUSON Redwood Diagnostic Ultrasound System
ACUSON SC2000 Diagnostic Ultrasound System
ACUSON NX3 Elite Diagnostic Ultrasound System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device