X-Porte Ultrasound System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- SonoSite X-Porte EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- X-PORTE ULTRASOUND SYSTEM EUDAMED
- Model / Reference
- X-PORTE ULTRASOUND SYSTEM EUDAMEDP19220-21 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- P19220 FDA UDI
- Primary DI / UDI-DI
- 00841517104412 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517104412 EUDAMED
- 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
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The X-Porte Ultrasound System is a portable diagnostic ultrasound device classified under nomenclature code Z11040103. It is designed for real-time imaging of internal body structures, enabling clinicians to assess organs, tissues, and fluid collections for diagnostic purposes in various clinical settings.
This non-sterile, non-reusable device is intended for single-use applications in point-of-care environments. It is not implantable or intended for MRI use. Supplied as a Class IIa medical device, it carries FDA 510(k) clearance and complies with the Medical Device Directive (MDD). The system is distributed under the Basic UDI B-00841517104412 and is manufactured by Fujifilm Sonosite, Inc.
Frequently asked questions
What clinical settings is the SonoSite X-Porte designed to support with its imaging capabilities?
The SonoSite X-Porte is specifically designed for real-time imaging of internal body structures in point-of-care environments, enabling clinicians to assess organs, tissues, and fluid collections. Its portability makes it ideal for emergency departments, intensive care units, surgical suites, and other settings where quick diagnostic imaging is critical. It is not intended for MRI environments or implantable procedures.
Is the SonoSite X-Porte reusable, and if not, what does that mean for clinical workflows?
No, the SonoSite X-Porte is not reusable—it is explicitly designed for single-use applications. This means each unit is intended for one procedure or patient encounter, reducing the risk of cross-contamination and simplifying disposal. Clinicians should treat it as a non-sterile, disposable device, ensuring proper handling and compliance with infection control protocols.
How do I identify the correct model and regulatory compliance of this device when ordering?
The SonoSite X-Porte is identified by its trade name (SonoSite X-Porte) and Basic UDI (B-00841517104412). It is classified as a Class IIa medical device under the FDA 510(k) clearance (K133134) and complies with the Medical Device Directive (MDD). The device was reviewed by the Radiology Advisory Committee and is manufactured by Fujifilm Sonosite, Inc. in the U.S., ensuring traceability through its assigned UDI.
What storage or handling precautions should be taken for the SonoSite X-Porte before use?
Since the SonoSite X-Porte is non-sterile and non-reusable, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The device is not sterilized for reuse, so clinicians must ensure it remains uncontaminated before use. Proper packaging and adherence to manufacturer guidelines for transport and setup are recommended to maintain functionality and safety.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Portable, Point-of-Care Ultrasound | FUJIFILM Sonosite, Tragbare Point-of-Care-Ultraschallgeräte | FUJIFILM Sonosite, Ultraschallgeräte | Fujifilm [Deutschland], Ultraschallgeräte | Fujifilm [Deutschland], Fujifilm (SonoSite) Ultraschall-Geräte kaufen - Medizinio
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142017 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171437 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K133134 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K152209 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00841517104412 | 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 e8c21e1c-c5db-4732-b8d1-b8ecec80a4b5 85 fields · synced Sep 18, 2026
- FDA UDI 42a69dc4-cb43-4c01-a605-ab2db7792c6b 35 fields · synced May 29, 2026
- FDA 510(k) K142017 1 fields · synced May 18, 2026