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SonoSite SII
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref P30381-15Model SONOSITE SII ULTRASOUND SYSTEM, 4.1510(k) K160734
Identity
- Trade Name
- SonoSite SII EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- SONOSITE SII ULTRASOUND SYSTEM, 4.1 EUDAMEDDiagnostic ultrasound device FDA UDI
- Model / Reference
- SONOSITE SII ULTRASOUND SYSTEM, 4.1 EUDAMEDP30381-15 EUDAMEDFDA UDI
- Description
- Diagnostic ultrasound device FDA UDI
Identifiers
- Catalog Number
- P30381 FDA UDI
- Primary DI / UDI-DI
- 00841517109783 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517109783 EUDAMED
- 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
SonoSite SII by Fujifilm Sonosite, Inc. — Class IIa — FDA_510K, MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183235 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160734 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00841517109783 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-00841517109783 | 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 1cd446aa-2868-42cb-aec2-4b5e272b7bd4 85 fields · synced Jun 18, 2026
- FDA UDI d23ccc5c-7eab-42de-a2af-d5b21e4d1e95 35 fields · synced May 30, 2026
- FDA 510(k) K183235 1 fields · synced May 18, 2026