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Voluson S10 Expert
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Voluson S10 Expert BT22 / 5880987Model Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6
Identity
- Trade Name
- Voluson S10 Expert EUDAMEDVoluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6 EUDAMEDVoluson S10 Expert BT22 FDA UDI
- Model / Reference
- Voluson S10 Expert, Voluson S10, Voluson S8t, Voluson S8, Voluson S6 EUDAMEDVoluson S10 Expert BT22 / 5880987 EUDAMEDS10 Expert BT22 FDA UDI
- Description
- Voluson S10 Expert BT22 FDA UDI
Identifiers
- Catalog Number
- VOLUSON-S10Expert-BT22 FDA UDI
- Primary DI / UDI-DI
- 00195278473042 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00209H8 EUDAMED
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040101 INTERNAL ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Unsafe FDA UDI
Voluson S10 Expert by Ge Ultrasound Korea, Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180374 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213642 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00209H8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Ultrasound Korea, Ltd.
- EUDAMED SRN
- KR-MF-000001860
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED d21bf393-bcf5-4b70-b61c-59654f2fa910 61 fields · synced Sep 18, 2026
- FDA UDI c2a07c17-5dea-424f-9afc-2e9c0b322894 37 fields · synced May 30, 2026
- FDA 510(k) K180374 1 fields · synced May 18, 2026