Identity
- Trade Name
- syngo SC2000 Workplace FDA UDI
- Generic Name
- Ultrasound imaging system workstation FDA UDI
- Model / Reference
- 10433921 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869003504 FDA UDI
- 510(k) Number
- K141846 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Ultrasound imaging system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound imaging system workstation
syngo SC2000 Workplace by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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- C6F2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- C7F2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- C8F3 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- CH5-2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
- EC9-4 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Medical Solutions Usa, Inc.
Sources (1)
- FDA UDI 48b179c2-223a-4528-a201-f542ba10ff8f 34 fields · synced Jun 8, 2026