P12 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

P12 Elite

Model / Reference

P12 Elite

Primary DI / UDI-DI

06945868607111

Basic UDI-DI

69458686U1015SL

510(k) Number

K221089 ↗

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 clinical applications is the P12 Elite Series Digital Color Doppler Ultrasound System primarily designed for?

  The P12 Elite Series is designed for visualizing blood flow and organ perfusion using real-time ultrasound imaging with color Doppler technology. Clinicians use it to assess vascular conditions, evaluate organ perfusion, and analyze cardiac function, making it ideal for diagnosing and monitoring hemodynamic and structural issues in clinical, hospital, or diagnostic settings.

• Is the P12 Elite Series Digital Color Doppler Ultrasound System intended for single-use or reusable applications?

  The P12 Elite Series is explicitly supplied as a reusable medical instrument. While it operates under sterile conditions during direct patient care procedures, the device itself is not single-use and requires proper cleaning, maintenance, and storage to ensure performance and safety over repeated uses.

• How is the device regulated, and what does its FDA clearance status mean for buyers?

  The P12 Elite Series holds FDA 510(k) clearance (K221089) under the *Radiology* advisory committee, confirming it is deemed *substantially equivalent* to a legally marketed predicate device. This means it meets FDA safety and effectiveness requirements for diagnostic ultrasound systems, ensuring compliance with U.S. regulatory standards for clinical use.

• What storage and maintenance guidelines should buyers follow to maintain the device’s performance?

  The manufacturer provides specific storage and maintenance guidelines to preserve the device’s performance and safety. Buyers should adhere to these protocols, which likely include environmental controls (e.g., temperature, humidity), regular cleaning procedures, and scheduled servicing to prevent degradation or malfunctions in the reusable P12 Elite Series system.

• Does the P12 Elite Series support high-resolution imaging for complex diagnostic evaluations?

  Yes, the device is engineered to deliver high-resolution imaging, combining color Doppler functionality with real-time ultrasound. This capability enables detailed visualization of blood flow and tissue structures, making it suitable for complex evaluations like assessing vascular conditions, organ perfusion, and cardiac function in clinical settings.