FDA Registration
Active
🇺🇸 United States
ACUSON Sequoia Diagnostic Ultrasound System
Reg #: 3023245
·
FEI: 3023245
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
3
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
- K221500
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 | 2022-06-17 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-06-17 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2022-06-17 |
| Biopsy Needle Guide Kit | OIJ | Class 2 | Radiology | No | 2022-06-17 |
Proprietary Names
ACUSON Sequoia 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