Identity
- Trade Name
- ACUSON S2000 Automated Breast Volume Scanner FDA UDI
- Generic Name
- Breast ultrasound imaging system FDA UDI
- Model / Reference
- 10434730 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056869002767 FDA UDI
- 510(k) Number
- K081148 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Breast ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 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
Yes
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: Breast ultrasound imaging system
ACUSON S2000 Automated Breast Volume Scanner by Siemens Medical Solutions Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breast ultrasound imaging system.
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- Invenia — GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC · Class III
- Invenia — GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Class III
- SonoCine Image Acquisition Station — Sonocine, Inc. · Class II
- SoftVue — Delphinus Medical Technologies · Class III
- Invenia — GE Medical Systems Ultrasound & Primary Care Diagnostics LLC · Class III
- Breast Volume Navigator (BVN) — Metritrack, Inc. · Class II
- SOFIA — IVU IMAGING CORPORATION · Class II
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 512a6473-9d69-4125-b988-b9864555721a 35 fields · synced Jun 8, 2026