Sonosite LX and Sonosite PX Ultrasound Systems
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SonoSite LX EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- SONOSITE LX ULTRASOUND SYSTEM EUDAMEDDiagnostic Ultrasound System FDA UDI
- Model / Reference
- P28354-35 EUDAMEDFDA UDISONOSITE LX ULTRASOUND SYSTEM EUDAMED
- Description
- Diagnostic Ultrasound System FDA UDI
Identifiers
- Catalog Number
- P28354 FDA UDI
- Primary DI / UDI-DI
- 00841517109905 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171LX8B EUDAMED
- FDA Product Code
- IYN FDA 510(k)FDA UDIITX 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 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)FDA UDI892.1570 FDA UDI892.1560 FDA UDI
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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 Sonosite LX and Sonosite PX Ultrasound Systems are portable diagnostic imaging devices classified as ultrasound machines. These systems generate real-time visual images of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and blood flow for diagnostic purposes. Designed for point-of-care applications, they support rapid decision-making in clinical settings such as emergency rooms, intensive care units, and procedural areas. Their compact and mobile design facilitates use in diverse environments where traditional imaging may be impractical.
These systems are intended for single-use or reusable configurations depending on the transducer and accessories, though regulatory data does not specify sterility requirements. Both models are approved under FDA 510(k) clearance (K251106) and comply with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). They are classified under product code IYN (Radiology Devices) and are intended for use in clinical settings where immediate diagnostic imaging is required. No specific MRI safety classification or storage conditions are noted in the provided data.
Frequently asked questions
Are the Sonosite LX and PX ultrasound systems designed for use in environments where space is limited, like emergency rooms or ambulances?
Yes, both the Sonosite LX and PX systems are explicitly designed as portable diagnostic imaging devices with a compact and mobile design. This makes them ideal for point-of-care settings like emergency rooms, intensive care units, and procedural areas where traditional imaging equipment may not be practical due to space constraints.
How are the transducers and accessories for these ultrasound systems intended to be used—single-use or reusable—and what does that mean for clinical workflows?
The Sonosite LX and PX systems support both single-use and reusable configurations depending on the specific transducer and accessories used. This flexibility allows clinicians to choose based on infection control protocols, patient volume, and workflow efficiency. For example, single-use transducers reduce the need for cleaning and reprocessing, while reusable ones may be cost-effective for high-volume settings with proper sterilization procedures.
What types of clinical assessments can these ultrasound systems help with, and why are they particularly useful in urgent care settings?
The Sonosite LX and PX systems generate real-time images of internal body structures, enabling clinicians to assess organs, tissues, and blood flow. This capability is particularly valuable in urgent care settings like emergency rooms or intensive care units, where rapid decision-making is critical. Their portability and point-of-care design allow for immediate imaging without transferring patients to a radiology department, which can be life-saving in time-sensitive scenarios.
Are there any specific storage requirements mentioned for the Sonosite LX and PX ultrasound systems, such as environmental conditions or handling instructions?
The provided data does not specify any particular storage conditions (e.g., temperature, humidity) or environmental requirements for the Sonosite LX and PX systems. However, standard best practices for electronic medical devices—such as protecting them from extreme temperatures, moisture, or physical damage—should be followed to ensure optimal performance and longevity. Since they are portable, care should be taken during transport to avoid impacts or exposure to harsh conditions.
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: Sonosite LX | FUJIFILM Sonosite, Sonosite PX Portable Ultrasound Machine | FUJIFILM Sonosite, Sonosite LX | Optimal Access. Unlimited Potential., Sonosite LX and Sonosite PX Ultrasound Systems
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251106 | Class II | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
Sources (3)
- FDA 510(k) K251106 24 fields · synced Sep 20, 2026
- FDA UDI f11d9be7-62be-4c20-b60e-7b70dccbdf39 36 fields · synced May 30, 2026
- EUDAMED a990a277-23e3-4161-8d8a-f0587e7a1baf 61 fields · synced Jul 27, 2026