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LOGIQ Fortis
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LOGIQ Fortis R3 to R4 SW Upgrade / 5946725Model LOGIQ Fortis
Identity
- Trade Name
- LOGIQ FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- LOGIQ Fortis EUDAMEDLOGIQ Fortis R3 to R4 SW Upgrade FDA UDI
- Model / Reference
- LOGIQ Fortis EUDAMEDLOGIQ Fortis R3 to R4 SW Upgrade / 5946725 EUDAMEDFortis R3 to R4 SW Upgrade FDA UDI
- Description
- LOGIQ Fortis R3 to R4 SW Upgrade FDA UDI
Identifiers
- Catalog Number
- 5946725 FDA UDI
- Primary DI / UDI-DI
- 00195278835741 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00214GZ EUDAMED
- 510(k) Number
- K231989 FDA UDI
- 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
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
MR Unsafe FDA UDI
LOGIQ Fortis by Ge Ultrasound Korea, Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8406821BUG00214GZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 3894e657-a3c8-4c53-950f-f9e56d3a9500 61 fields · synced May 30, 2026
- FDA UDI 24ad8301-6b2d-42bf-9b41-6353c2d9b820 36 fields · synced May 30, 2026