P20 Elite Series 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

P20 Elite

Model / Reference

P20 Elite

Primary DI / UDI-DI

06945868606435

Basic UDI-DI

69458686U1016SN

510(k) Number

K221140 ↗

FDA Product Code

IYN

EMDN Code

Z11040104 Multidisciplinary ultrasound scanners (internal and cardiology, etc.)

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 892.1550

EU market of registration

Netherlands

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sonoscape Medical Corp. →

• What types of medical conditions can this ultrasound system help diagnose or monitor using its color Doppler capabilities?

  The P20 Elite Series Digital Color Doppler Ultrasound System is designed to visualize blood flow within vessels and organs, making it particularly useful for assessing cardiovascular conditions (like blood vessel blockages or heart function), obstetric evaluations (such as fetal development and placental blood flow), and abdominal studies (including liver, kidney, or vascular abnormalities). The color Doppler feature helps clinicians differentiate between normal and abnormal flow patterns, aiding in diagnostic decision-making.

• Is this device single-use or reusable, and what maintenance does it require?

  The P20 Elite Series is a reusable medical device, meaning it is intended for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. Since it is classified as a reusable system, it requires adherence to manufacturer guidelines for calibration, servicing, and routine upkeep to ensure optimal performance and safety. Regular maintenance is critical to prevent electromagnetic interference (EMI) and maintain imaging accuracy.

• How is this ultrasound system regulated, and what does that mean for its safety and compliance?

  The P20 Elite Series holds FDA 510K clearance and MDR compliance, meaning it has undergone regulatory review to demonstrate substantial equivalence to a previously cleared device (under the FDA’s 510(k) pathway) and meets European medical device regulations. This ensures it adheres to strict safety, performance, and quality standards before being marketed. Clinicians can rely on its compliance as evidence of rigorous testing and validation.

• What storage and handling precautions should be taken for this device to ensure proper functionality?

  While the P20 Elite Series is not described as sterile, its storage and handling should follow clinical protocols to prevent contamination and ensure reliability. Special attention must be given to electromagnetic interference (EMI) safety, as ultrasound systems are sensitive to external electromagnetic fields. Additionally, if used in environments with MRI equipment, the device’s MRI compatibility (as outlined in its technical specifications) should be respected to avoid interference or damage. Always store in a clean, dry environment away from direct sunlight or extreme temperatures.