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4D View 18
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 5789738510(k) K253639
Identity
- Trade Name
- 4D View 18 EUDAMED4D View FDA UDI
- Generic Name
- Ultrasound imaging system operation software FDA UDI
- Device Name
- 4D View 18 EUDAMED
- Model / Reference
- 5789738 EUDAMED18 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682137621 EUDAMEDFDA UDI
- Basic UDI-DI
- 08406821BUG004647E EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11040192 ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Ultrasound imaging system operation software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
4D View 18 by GE Healthcare Austria GmbH & Co OG — Class IIa — FDA_510K, 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253639 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K131118 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08406821BUG004647E | Class IIa | Active |
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Manufacturer
- Manufacturer
- GE Healthcare Austria GmbH & Co OG
- EUDAMED SRN
- AT-MF-000001461
- FDA Applicant
- GE Healthcare
Sources (4)
- EUDAMED 7157cdd5-bd54-45c2-95ca-5b1db4a97916 85 fields · synced Oct 6, 2026
- FDA UDI 11458ee2-baa3-4ee7-aed4-eedbefd1d97a 33 fields · synced May 30, 2026
- EUDAMED 90255246-6e33-4c34-8a63-c421c39b63db 61 fields · synced Jul 22, 2026
- FDA 510(k) K253639 1 fields · synced May 18, 2026