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FC1 Ultrasound System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref P16951-22Model FC1 ULTRASOUND SYSTEM
Identity
- Trade Name
- FC1 Ultrasound System EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- FC1 ULTRASOUND SYSTEM EUDAMED
- Model / Reference
- FC1 ULTRASOUND SYSTEM EUDAMEDP16951-22 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517100940 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517100940 EUDAMED
- 510(k) Number
- K160406 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO 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
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 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
FC1 Ultrasound 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160406 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00841517100940 | 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 cbdf8b8c-fa40-46d7-b668-08f4c8c57144 61 fields · synced Jun 20, 2026
- FDA UDI 46039548-6a96-4c46-90bd-46a2ed1a78e6 35 fields · synced May 29, 2026
- FDA 510(k) K160406 1 fields · synced May 18, 2026