X5 Digital Color Doppler Ultrasound System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

X5 EUDAMED

SonoScape GUDID

Generic Name

General-purpose ultrasound imaging system

Model / Reference

X5

Primary DI / UDI-DI

06945868695002

Basic UDI-DI

69458686U1007SM

510(k) Number

K160258 ↗

FDA Product Code

IYN, ITX, IYO

EMDN Code

Z11040103 Portable ultrasound scanners

GMDN Term

General-purpose ultrasound imaging system

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.1550 510(k)GUDID

892.1570 GUDID

892.1560 GUDID

EU market of registration

Netherlands

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• Is the X5 Digital Color Doppler Ultrasound System designed for single-use or can it be reused between patients?

  The X5 is a reusable device, meaning it is intended for repeated use across multiple patients. Since it is not single-use, it must undergo proper sterilization protocols between uses to ensure safety and hygiene in clinical settings.

• What types of clinical environments is the X5 Digital Color Doppler Ultrasound System suitable for, and how does its portability factor into its use?

  The X5 is specifically designed for clinical, portable, and point-of-care settings, including bedside use and mobile applications like ambulances. Its compact, laptop-style form factor makes it easy to transport and operate in diverse environments, ensuring flexibility for healthcare providers.

• How does the X5 Digital Color Doppler Ultrasound System differ from standard ultrasound machines in terms of its capabilities?

  The X5 incorporates Color Doppler technology, allowing it to visualize blood flow within vessels and organs in real time. This distinguishes it from standard ultrasound machines, which may lack Doppler capabilities, enabling assessments of vascular conditions, cardiac function, and anatomical structures with dynamic flow information.

• What regulatory pathways has the X5 Digital Color Doppler Ultrasound System followed, and what does this mean for its use in healthcare settings?

  The X5 has undergone FDA 510(k) clearance (K160258) and meets MDR compliance, confirming its safety and performance standards for use in the U.S. and EU markets. The clearance was determined through a Radiology (RA) advisory committee review, ensuring it is substantially equivalent to existing devices in its category (Product Code: IYN).

• What form factor does the X5 Digital Color Doppler Ultrasound System have, and how does this impact its usability in different settings?

  The X5 features a compact, laptop-style form factor, making it lightweight and easy to transport. This design is particularly advantageous for bedside, mobile, and point-of-care applications, such as ambulances, where space and portability are critical factors in clinical decision-making.