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E-Cube 7

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121729

by ALPINION MEDICAL SYSTEMS Co., Ltd.

Identifiers

510(k) Number
K121729 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The E-Cube 7 is a diagnostic ultrasound system designed for imaging applications. It utilizes core imaging technology to provide 2D, Color Flow, and CW/PW Doppler performance.

This system is supplied as a compact unit and is authorized under FDA 510k clearance K121729. It is compatible with various transducers, including single crystal convex and phased array models.

Frequently asked questions

What imaging modes does the E-CUBE 7 support?

The E-CUBE 7 is designed for diagnostic ultrasound imaging and supports 2D, Color Flow, and both Continuous Wave (CW) and Pulsed Wave (PW) Doppler performance to assist in clinical imaging applications.

Is the E-CUBE 7 compatible with different types of transducers?

Yes, the system is compatible with various transducer models, including single crystal convex and phased array models, allowing for flexibility in diagnostic imaging procedures.

What is the regulatory status of the E-CUBE 7?

The E-CUBE 7 is authorized under FDA 510k clearance K121729. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: ALPINION, E-CUBE 7 - Alpinion Medical Systems - PDF Catalogs | Technical ..., ALPINION

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
ALPINION MEDICAL SYSTEMS Co., Ltd.

Sources (1)

  • FDA 510(k) K121729 24 fields · synced Oct 6, 2026