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Voluson Expert 18, Voluson Expert 20, Voluson Expert 22
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Voluson Expert 22 BT24510(k) K231965
Identity
- Trade Name
- Voluson FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Voluson Expert 18, Voluson Expert 20, Voluson Expert 22 EUDAMEDVoluson Expert 22 BT24 FDA UDI
- Model / Reference
- Voluson Expert 22 BT24 EUDAMEDExpert 22 BT24 FDA UDI
- Description
- Voluson Expert 22 BT24 FDA UDI
Identifiers
- Catalog Number
- 5934552 FDA UDI
- Primary DI / UDI-DI
- 00195278699848 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00372HL EUDAMED
- Direct Marketing DI
- 00195278699848 EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 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
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
Voluson Expert 18, Voluson Expert 20, Voluson Expert 22 by GE Healthcare Austria GmbH & Co OG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA…
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 | K220358 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K231965 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00372HL | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Austria GmbH & Co OG
- EUDAMED SRN
- AT-MF-000001461
- FDA Applicant
- GE Medical Systems Ultrasound and Primary Care Diagnostics
Sources (4)
- EUDAMED 5339bf9e-f0ad-40eb-ab92-918b2b999ba3 85 fields · synced Oct 9, 2026
- FDA UDI 105c0fb5-33e3-457a-9593-4d48474d3175 37 fields · synced May 30, 2026
- EUDAMED 3a25863d-a696-4612-9a79-36f0f26b21a0 61 fields · synced Jun 18, 2026
- FDA 510(k) K220358 1 fields · synced May 18, 2026