FDA Registration
Active
🇺🇸 United States
SIEMENS MEDICAL SOLUTIONS USA, INC.
Reg #: 3023245
·
FEI: 3023245
·
Expires 2026
Products
9
Proprietary Names
48
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Registration Number
- 3023245
- FEI Number
- 3023245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 22010 S.E. 51ST ST.
- City
- ISSAQUAH
- State
- WA
- ZIP
- 98029
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193257
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, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2020-02-03 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2020-02-03 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2020-02-03 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2022-08-22 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2018-01-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-06-13 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-06-17 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2019-08-08 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2013-01-23 |
Proprietary Names
ACUSON Sequoia Diagnostic Ultrasound System
ACUSON Juniper Select Diagnostic Ultrasound System
ACUSON Juniper Diagnostic Ultrasound System
ACUSON NX3 Elite Diagnostic Ultrasound System
ACUSON NX3 Diagnostic Ultrasound System
Acuson Freestyle Diagnostic Ultrasound System
ACUSON AcuNav Volume ICE Catheter
AcuNav 10F Diagnostic Ultrasound Catheter
AcuNav 8F Diagnostic Ultrasound Catheter
ACUSON SC2000 Diagnostic Ultrasound System
ACUSON P500 Diagnostic Ultrasound System
ACUSON Sequoia Select Diagnostic Ultrasound System
ACUSON Origin Diagnostic Ultrasound System
ACUSON Origin ICE Diagnostic Ultrasound System
ACUSON P500 Ultrasound System
ACUSON P500 ICE Ultrasound System
ACUSON Redwood Diagnostic Ultrasound System
ACUSON P200 Diagnostic Ultrasound System
ACUSON Freestyle Diagnostic Ultrasound System
ACUSON Maple Diagnostic Ultrasound System
ACUSON Maple Select Diagnostic Ultrasound System
eSie Apps Suite
syngo Ultrasound Apps Suite
ACUSON Antares Diagnostic Ultrasound System
ACUSON S2000 ABVS Ultrasound System
AcuNav Lumos 4D ICE Catheter
AcuNav Volume ICE Catheter
AcuNav Crystal Ultrasound Catheter
AcuNav Crystal G Ultrasound Catheter
Acuson S2000 Diagnostic Ultrasound System
Acuson S1000 Diagnostic Ultrasound System
Acuson S3000 Diagnostic Ultrasound System
ACUSON Redwood Ultrasound System
syngo Ultrasound Breast Analysis (sUSBA)
ACUSON S1000 Diagnostic Ultrasound System
ACUSON S2000 Diagnostic Ultrasound System
ACUSON S3000 Diagnostic Ultrasound System
ACUSON Oxana Diagnostic Ultrasound System
ACUSON X800 Diagnostic Ultrasound System
Elegra Diagnostic Ultrasound System
ACUSON S Family (S1000/ S2000 / S3000) Diagnostic Ultrasound System
ACUSON X700 Diagnostic Ultrasound System
ACUSON X600 Diagnostic Ultrasound System
ACUSON NX2 Diagnostic Ultrasound System
ACUSON NX2 Elite Diagnostic Ultrasound System
ACUSON X300 Diagnostic Ultrasound System
ACUSON X300PE Diagnostic Ultrasound System
G60 Diagnostic Ultrasound System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device