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Vevo MD Imaging System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 51475-40Model VEVO MD IMAGING SYSTEM (120V)510(k) K160674
Identity
- Trade Name
- Vevo MD Imaging System EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- VEVO MD IMAGING SYSTEM (120V) EUDAMEDDiagnostic ultrasound system FDA UDI
- Model / Reference
- VEVO MD IMAGING SYSTEM (120V) EUDAMED51475-40 EUDAMEDFDA UDI
- Description
- Diagnostic ultrasound system FDA UDI
Identifiers
- Catalog Number
- 51475 FDA UDI
- Primary DI / UDI-DI
- 00841517103248 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517103248 EUDAMED
- 510(k) Number
- K160674 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS 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
- 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
No
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
Yes
FDA UDI
Vevo MD Imaging System by Fujifilm Sonosite, Inc. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190476 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160674 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00841517103248 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (3)
- EUDAMED 5c968c5f-ec82-46dc-a998-bfec77ee1043 85 fields · synced Jun 18, 2026
- FDA UDI 463dfb8a-6e09-419e-a625-7d84ea83a014 37 fields · synced May 30, 2026
- FDA 510(k) K190476 1 fields · synced May 18, 2026