FDA Registration
Active
🇺🇸 United States
ACUSON Sequoia Select Diagnostic Ultrasound System
Reg #: 3023245
·
FEI: 3023245
·
Expires 2025
Products
6
Proprietary Names
4
Establishment Types
3
Classifications
6
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
- K242523
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 |
|---|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-11-20 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2024-11-20 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2024-11-20 |
| Catheter, Ultrasound, Intravascular | OBJ | Class 2 | Cardiovascular | No | 2024-11-20 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2024-11-20 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2024-11-20 |
Proprietary Names
ACUSON Sequoia Select Diagnostic Ultrasound System
ACUSON Origin Diagnostic Ultrasound System
ACUSON Sequoia Diagnostic Ultrasound System
ACUSON Origin ICE 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